Dysport® Adult Lower Limb Spasticity Study

Completed

Phase 3 Results

Update History

18 Oct '17
The Summary of Purpose was updated.
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The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
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The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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Inclusion Criteria: - Subjects aged 18 to 80 years of age - Post stroke or brain injury - Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale - Ambulatory patients Exclusion Criteria: - Fixed contractures - Physiotherapy initiated less than 4 weeks before entry - Previous surgery or previous treatment with phenol and/or alcohol in lower limb - Neurological/neuromuscular disorders which may interfere with protocol evaluations
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Inclusion Criteria: - Subjects aged 18 to 80 years of age - Post stroke or brain injury - Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale - Ambulatory patients Exclusion Criteria: - Fixed contractures - Physiotherapy initiated less than 4 weeks before entry - Previous surgery or previous treatment with phenol and/or alcohol in lower limb - Neurological/neuromuscular disorders which may interfere with protocol evaluations
21 Dec '13
A location was updated in Scottsdale.
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The overall status was removed for Mayo Clinic Arizona.
A location was updated in Downey.
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The overall status was removed for Rancho Los Amigos.
A location was updated in Oxnard.
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The overall status was removed for Pacific Neuroscience Medical Group.
A location was updated in Fairfield.
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The overall status was removed for Associated Neurologist of Southern CT, PC.
A location was updated in Boca Raton.
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The overall status was removed for Parkinson's Disease & Movement Disorders Center of Boca Raton.
A location was updated in Doral.
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The overall status was removed for Design Neuroscience Center.
A location was updated in New York.
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The overall status was removed for Mount Sinai School of Medicine.
A location was updated in New York.
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The overall status was removed for Weill Cornell Medical College.
A location was updated in Chapel Hill.
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The overall status was removed for Univ of North Carolina - Chapel Hill.
A location was updated in Winston Salem.
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The overall status was removed for Wake Forest University Baptist Medical Center.
A location was updated in Elkins Park.
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The overall status was removed for MossRehab & Albert Einstein.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University.
A location was updated in Dallas.
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The overall status was removed for The University of Texas Southwestern Medical Center at Dallas.
A location was updated in Fort Worth.
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The overall status was removed for University of North Texas HSC at Ben Hogan Center.
A location was updated in Houston.
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The overall status was removed for University of Texas - Houston.
A location was updated in Salt Lake City.
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The overall status was removed for University of Utah School of Medecine.
A location was updated in Darlinghurst.
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The overall status was removed for Saint Vincent's Hospital.
A location was updated in Fitzroy.
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The overall status was removed for Saint Vincent's Hospital.
A location was updated in Kogarah.
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The overall status was removed for St George Hospital.
A location was updated in Parkville.
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The overall status was removed for Royal Melbourne Hospital.
A location was updated in Richmond.
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The overall status was removed for Epworth Rehabilitation.
A location was updated in Westmead.
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The overall status was removed for Westmead Hospital.
A location was updated in Bruxelles.
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The overall status was removed for Université catholique de Louvain av Hippocrate 10.
A location was updated in Yvoir.
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The overall status was removed for Clinique Universitaire.
A location was updated in Praha 2.
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The overall status was removed for Charles University in Prague.
A location was updated in Besançon.
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The overall status was removed for CHU Jean MINJOZ.
A location was updated in Coubert.
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The overall status was removed for Centre de Réadaptation de Coubert.
A location was updated in Créteil.
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The overall status was removed for Centre Hospitalier Albert Chenevier-Hopital Henri Mondor.
A location was updated in Garches.
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The overall status was removed for Hopital Raymond Poincarré.
A location was updated in Nice.
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The overall status was removed for Hôpital de L'Archet.
A location was updated in Reims.
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The overall status was removed for Hôpital Sébastopol.
A location was updated in Strasbourg.
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The overall status was removed for Hopital Hautepierre.
A location was updated in Strasbourg.
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The overall status was removed for Nouvel Civil Hospital.
A location was updated in Toulouse.
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The overall status was removed for Hopital Rangueil.
A location was updated in Budapest.
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The overall status was removed for National Institute for Medical Rehabilitation.
A location was updated in Budapest.
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The overall status was removed for Szent János Hospital.
A location was updated in Budapest.
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The overall status was removed for Uno Medical Trials.
A location was updated in Gyor.
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The overall status was removed for Petz Aladar Country Hospital.
A location was updated in Kisbér.
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The overall status was removed for Batthyány Kázmér Hospital.
A location was updated in Catania.
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The overall status was removed for Azienda Ospedaliero.
A location was updated in Fossano.
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The overall status was removed for SSD Neurofisiologia Riabilitativa.
A location was updated in Milano.
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The overall status was removed for Servizio di Neurofisiologia Clinica-Ospedale San Raffaele.
A location was updated in Parma.
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The overall status was removed for Unità Operativa Medicina Riabilitativa.
A location was updated in Treviso.
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The overall status was removed for Polo IRCCS Eugenio Medea La Nostra Famiglia.
A location was updated in Katowice.
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The overall status was removed for Specjalistyczna Praktyka Lekarska.
A location was updated in Krakow.
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The overall status was removed for Malopolskie Centrum Medyczne.
A location was updated in Krakow.
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The overall status was removed for Krakowska Akademia Neurologii.
A location was updated in Krakow.
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The overall status was removed for Centrum Medyczne Plejady.
A location was updated in Poznan.
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The overall status was removed for Nzoz Neuro - Card.
A location was updated in Warsaw.
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The overall status was removed for Samodzielny Publiczny Centralny Szpinal.
A location was updated in Alcabideche.
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The overall status was removed for Servicio de Rehabilitation de Adultos.
A location was updated in Lisbon.
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The overall status was removed for Centro Hospitalar Lisboa Norte.
A location was updated in Porto.
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The overall status was removed for Centro Hospitalar São João.
A location was updated in Moscow.
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The overall status was removed for Medical Rehabilitation Center.
A location was updated in Moscow.
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The overall status was removed for Scientific Research Institute of Neurology.
A location was updated in St Petersburg.
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The overall status was removed for State university.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
31 Oct '13
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
9 Oct '13
A location was updated in Budapest.
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The overall status was removed for Uno Medical Trials.
A location was updated in Gyor.
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The overall status was removed for Petz Aladar Country Hospital.
A location was updated in Fossano.
New
The overall status was removed for SSD Neurofisiologia Riabilitativa.
A location was updated in Parma.
New
The overall status was removed for Unità Operativa Medicina Riabilitativa.
A location was updated in Katowice.
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The overall status was removed for Specjalistyczna Praktyka Lekarska.
A location was updated in Poznan.
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The overall status was removed for Nzoz Neuro - Card.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
18 Jul '13
A location was updated in Boca Raton.
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The overall status was updated to "Active, not recruiting" at Parkinson's Disease & Movement Disorders Center of Boca Raton.
A location was updated in Fort Worth.
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The overall status was removed for University of North Texas HSC at Ben Hogan Center.
A location was updated in Brest.
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The overall status was updated to "Withdrawn" at CHU Brest.
A location was updated in Budapest.
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The overall status was removed for Szent János Hospital.
A location was updated in Szeged.
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The overall status was updated to "Withdrawn" at University of Szeged.
A location was updated in Parma.
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The overall status was removed for Unità Operativa Medicina Riabilitativa.
A location was updated in Alcabideche.
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The overall status was removed for Servicio de Rehabilitation de Adultos.
A location was updated in Lisbon.
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The overall status was removed for Centro Hospitalar Lisboa Norte.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
1 Jun '13
A location was updated in Houston.
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The overall status was removed for University of Texas - Houston.
A location was updated in Caulfield.
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The overall status was updated to "Withdrawn" at Caulfield Hospital.
A location was updated in Olomouc.
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The overall status was updated to "Withdrawn" at University Hospital Olomouc.
A location was updated in Nice.
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The overall status was removed for Hôpital de L'Archet.
A location was updated in Budapest.
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The overall status was removed for National Institute for Medical Rehabilitation.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
3 Apr '13
A location was updated in Kogarah.
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The overall status was removed for St George Hospital.
A location was updated in Toulouse.
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The overall status was removed for Hopital Rangueil.
A location was updated in Warsaw.
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The overall status was removed for Samodzielny Publiczny Centralny Szpinal.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
28 Dec '12
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
2 Nov '12
A location was updated in Atlanta.
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The overall status was updated to "Withdrawn" at Shepherd Center.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
6 Sep '12
A location was updated in New York.
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The overall status was removed for Mount Sinai School of Medicine.
A location was updated in Elkins Park.
New
The overall status was removed for MossRehab & Albert Einstein.
A location was updated in Dallas.
New
The overall status was removed for The University of Texas Southwestern Medical Center at Dallas.
A location was updated in Garches.
New
The overall status was removed for Hopital Raymond Poincarré.
A location was updated in Krakow.
New
The overall status was removed for Krakowska Akademia Neurologii.
A location was updated in Bratislava.
New
The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
2 May '12
A location was updated in Downey.
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The overall status was removed for Rancho Los Amigos.
A location was updated in Miami.
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The overall status was updated to "Recruiting" at University of Miami.
A location was updated in New York.
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The overall status was removed for Weill Cornell Medical College.
A location was updated in Elkins Park.
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The overall status was removed for MossRehab & Albert Einstein.
A location was updated in Salt Lake City.
New
The overall status was removed for University of Utah School of Medecine.
A location was updated in Garches.
New
The overall status was removed for Hopital Raymond Poincarré.
A location was updated in Krakow.
New
The overall status was removed for Malopolskie Centrum Medyczne.
A location was updated in Moscow.
New
The overall status was removed for Medical Rehabilitation Center.
A location was updated in Moscow.
New
The overall status was removed for Scientific Research Institute of Neurology.
A location was updated in Bratislava.
New
The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
2 Feb '12
A location was updated in Fairfield.
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The overall status was removed for Associated Neurologist of Southern CT, PC.
A location was updated in Leawood.
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The overall status was updated to "Withdrawn" at International Clinical Research Institute.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University.
A location was updated in Bruxelles.
New
The overall status was removed for Université catholique de Louvain av Hippocrate 10.
A location was updated in Coubert.
New
The overall status was removed for Centre de Réadaptation de Coubert.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
1 Dec '11
A location was updated in Scottsdale.
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The overall status was removed for Mayo Clinic Arizona.
A location was updated in Fairfield.
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The overall status was removed for Associated Neurologist of Southern CT, PC.
A location was updated in Leawood.
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The overall status was updated to "Withdrawn" at International Clinical Research Institute.
A location was updated in Winston Salem.
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The overall status was removed for Wake Forest University Baptist Medical Center.
A location was updated in Nashville.
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The overall status was removed for Vanderbilt University.
A location was updated in Dallas.
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The overall status was updated to "Withdrawn" at Baylor Institute.
A location was updated in Houston.
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The overall status was updated to "Withdrawn" at Neurorehabilitation Specialist.
A location was updated in Praha 2.
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The overall status was removed for Charles University in Prague.
A location was updated in Besançon.
New
The overall status was removed for CHU Jean MINJOZ.
A location was updated in Créteil.
New
The overall status was removed for Centre Hospitalier Albert Chenevier-Hopital Henri Mondor.
A location was updated in Reims.
New
The overall status was removed for Hôpital Sébastopol.
A location was updated in St Petersburg.
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The overall status was removed for State university.
A location was updated in Bratislava.
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The overall status was removed for Univerzitna nemocnica Bratislava.
A location was updated in Bratislava.
New
The overall status was removed for Univerzitna nemocnica Bratislava.