Trial Condition(s):

Bronchiectasis

Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) (RESPIRE 1)

Bayer Identifier:

15625

ClinicalTrials.gov Identifier:

NCT01764841

EudraCT Number:

2011-004208-39

Study Completed

Trial Purpose

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Inclusion Criteria
- Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis
- Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks
Exclusion Criteria
- Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted
- Active allergic bronchopulmonary aspergillosis
- Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
- Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Trial Summary

Enrollment Goal
416
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
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Exeter, United Kingdom, EX2 5DW

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Completed
 
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Belfast, United Kingdom, BT12 7AB

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Completed
 
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Plymouth, United Kingdom, PL6 8DH

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Completed
 
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Torbay, United Kingdom, TQ2 7AA

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Completed
 
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London, United Kingdom, SW3 6NP

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Completed
 
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Manchester, United Kingdom, M23 9LT

Status
Terminated
 
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Pisa, Italy, 56124

Status
Completed
 
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Pavia, Italy, 27040

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Completed
 
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Benevento, Italy, 82037

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Completed
 
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Varese, Italy, 21049

Status
Completed
 
Locations

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Bari, Italy, 70020

Status
Terminated
 
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Cagliari, Italy, 09126

Status
Completed
 
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ADELAIDE, Australia, 5041

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Completed
 
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Hannover, Germany, 30625

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Completed
 
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Hannover, Germany, 30173

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Completed
 
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Berlin, Germany, 10717

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Completed
 
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Berlin, Germany, 10969

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Completed
 
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Heidelberg, Germany, 69126

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Terminated
 
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Barcelona, Spain, 08036

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Completed
 
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Sant Boi de Llobregat, Spain, 08830

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Completed
 
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Geesthacht, Germany, 21502

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Completed
 
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Koblenz, Germany, 56068

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Completed
 
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Berlin, Germany, 12203

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Completed
 
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CLERMONT FERRAND, France, 63000

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Completed
 
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MONTPELLIER, France, 34059

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Completed
 
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Terrassa, Spain, 08221

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Terminated
 
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Pontevedra, Spain, 36071

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Terminated
 
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L'Hospitalet, Spain, 08907

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Completed
 
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Santiago de Compostela, Spain, 15706

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Completed
 
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Barcelona, Spain, 08041

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Completed
 
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Madrid, Spain, 28034

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Terminated
 
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Madrid, Spain, 28006

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Completed
 
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Badalona, Spain, 08916

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Terminated
 
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Pozuelo de Alarcón, Spain, 28223

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Completed
 
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Oviedo, Spain, 33006

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Completed
 
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Elda, Spain, 03600

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Completed
 
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Valencia, Spain, 46017

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Terminated
 
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Hellerup, Denmark, 2900

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Completed
 
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Naestved, Denmark, 4700

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Completed
 
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Fukuoka, Japan, 811-1394

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Completed
 
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Sakai, Japan, 591-8555

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Completed
 
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Koshi, Japan, 861-1196

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Completed
 
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Nakagun, Japan, 319-1113

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Completed
 
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Kiyose, Japan, 204-8585

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Completed
 
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Matsusaka, Japan, 515-8544

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Completed
 
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Tsu, Japan, 514-1101

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Completed
 
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Hamamatsu, Japan, 434-8511

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Completed
 
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Toon, Japan, 791-0281

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Completed
 
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Mitaka, Japan, 181-8611

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Completed
 
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Frankston, Australia, 3199

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Completed
 
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Adelaide, Australia, 5000

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Completed
 
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Toorak Gardens, Australia, 5065

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Completed
 
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Box Hill, Australia, 3128

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Completed
 
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Woolloongabba, Australia, 4102

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Completed
 
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Woodville, Australia, 5011

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Completed
 
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NIMES, France, 30900

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Completed
 
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TOULON, France, 83000

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Completed
 
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Cairns, Australia, 4870

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Completed
 
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Parkville, Australia, 3050

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Completed
 
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PRAHRAN, Australia, 3181

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Completed
 
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Kogarah, Australia, 2217

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Completed
 
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Christchurch, New Zealand, 8011

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Completed
 
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Wellington, New Zealand, 6021

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Completed
 
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Hamilton, New Zealand, 3240

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Completed
 
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Auckland, New Zealand, 1051

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Completed
 
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Auckland, New Zealand, 1640

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Completed
 
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Tauranga, New Zealand, 3110

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Completed
 
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Wellington, New Zealand, 6021

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Terminated
 
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Dunedin, New Zealand

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Completed
 
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Los Angeles, United States, 90048

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Completed
 
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Lawrenceville, United States, 30046

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Completed
 
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Valencia, Spain, 46026

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Completed
 
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Winter Park, United States, 32789

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Completed
 
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Richmond, United States, 23225

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Completed
 
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Tacoma, United States, 98405

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Completed
 
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Chesterfield, United States, 63017

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Completed
 
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Michigan City, United States, 46360

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Completed
 
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Phoenix, United States, 85006-2611

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Completed
 
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Hazard, United States, 41701

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Completed
 
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Miami, United States, 33136

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Completed
 
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Torrance, United States

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Terminated
 
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Houston, United States, 77030

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Terminated
 
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Ventura, United States, 93003

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Terminated
 
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Tyler, United States, 75708-3154

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Completed
 
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New York, United States, 10016

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Terminated
 
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Abingdon, United States, 24210

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Completed
 
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Philadelphia, United States, 19140

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Terminated
 
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Waterbury, United States, 06708-2513

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Completed
 
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Summit, United States, 07901

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Terminated
 
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Flagstaff, United States, 86001

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Completed
 
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McKinney, United States, 75069

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Terminated
 
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Scottsdale, United States, 85258

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Terminated
 
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Fort Smith, United States, 72901

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Completed
 
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Marietta, United States, 30060

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Terminated
 
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Washington, United States, 20007-2197

Status
Completed
 
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Investigative Site

Farmington, United States, 06030

Status
Terminated
 
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New Hyde Park, United States, 11042

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Completed
 
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Charleston, United States, 29425

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Completed
 
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Orlando, United States, 32803

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Completed
 
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Kingwood, United States, 77339

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Completed
 
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Portland, United States, 97239-3011

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Completed
 
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Investigative Site

Houston, United States, 77043

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Completed
 
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Investigative Site

Jasper, United States, 35501

Status
Terminated
 
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Investigative Site

Philadelphia, United States, 19104

Status
Terminated
 
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Investigative Site

Rehovot, Israel, 7610001

Status
Completed
 
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Investigative Site

Ashkelon, Israel, 7827804

Status
Completed
 
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Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
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Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
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Investigative Site

Afula, Israel, 1834111

Status
Completed
 
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Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
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Investigative Site

Haifa, Israel, 3436212

Status
Completed
 
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Investigative Site

Beer Sheva, Israel, 8410101

Status
Completed
 
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Investigative Site

Tel Aviv, Israel, 6423906

Status
Completed
 
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Investigative Site

Petah Tikva, Israel, 4941492

Status
Completed
 
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Investigative Site

Cambridge, United Kingdom, CB23 3RE

Status
Completed
 
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Investigative Site

Londonderry, United Kingdom, BT47 6SB

Status
Completed
 
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Investigative Site

Trieste, Italy, 34149

Status
Completed
 
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Investigative Site

Roma, Italy, 00168

Status
Completed
 
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Investigative Site

Weston, United States, 33331

Status
Terminated
 
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Investigative Site

Chicago, United States, 60637

Status
Terminated
 
Locations

Investigative Site

Catania, Italy, 95123

Status
Completed
 
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Investigative Site

Vicente López, Argentina, 1638

Status
Terminated
 
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Investigative Site

Buenos Aires, Argentina, C1425DES

Status
Completed
 
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Investigative Site

Godoy Cruz, Argentina, 5501

Status
Completed
 
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Investigative Site

Verona, Italy, 37126

Status
Completed
 
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Investigative Site

Murdoch, Australia, 6150

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV-1002

Status
Completed
 
Locations

Investigative Site

Daugavpils, Latvia, LV-5410

Status
Completed
 
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Investigative Site

Kraslava, Latvia, 5601

Status
Completed
 
Locations

Investigative Site

Jurmala, Latvia, LV-2010

Status
Terminated
 
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Investigative Site

Riga, Latvia, LV-1011

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV-1038

Status
Completed
 
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Investigative Site

Daugavpils, Latvia, LV-5403

Status
Completed
 
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Investigative Site

Talsu, Latvia, 3201

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV-1001

Status
Completed
 
Locations

Investigative Site

Celebration, United States, 34747

Status
Terminated
 
Locations

Investigative Site

Celebration, United States, 34747

Status
Completed
 
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Investigative Site

Shrewsbury, United Kingdom, SY3 8XQ

Status
Completed
 
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Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

Cáceres, Spain, 10003

Status
Terminated
 
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Investigative Site

Bratislava, Slovakia, 821 06

Status
Completed
 
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Investigative Site

Presov, Slovakia, 080 01

Status
Completed
 
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Investigative Site

Hamburg, Germany, 22767

Status
Completed
 
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Investigative Site

Cottbus, Germany, 03050

Status
Completed
 
Locations

Investigative Site

Jena, Germany, 07740

Status
Completed
 
Locations

Investigative Site

Neu-Isenburg, Germany, 63263

Status
Completed
 
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Investigative Site

Frankfurt, Germany, 60389

Status
Completed
 
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Investigative Site

Aarhus C, Denmark, 8000

Status
Terminated
 
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Investigative Site

Roskilde, Denmark, 4000

Status
Completed
 
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Investigative Site

Spokane, United States, 99202-1334

Status
Terminated
 
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Investigative Site

Dundee, United Kingdom, DD1 9SY

Status
Completed
 
Locations

Investigative Site

Fort Worth, United States, 76104

Status
Completed
 

Trial Design