Trial Condition(s):

Contraception

Levonorgestrel contraceptive intrauterine systems (LCS) Pearl Index study

Bayer Identifier:

91665

ClinicalTrials.gov Identifier:

NCT00528112

EudraCT Number:

2007-000420-40

Study Completed

Trial Purpose

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Inclusion Criteria
- Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
 - Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
Exclusion Criteria
- Known or suspected pregnancy or is lactating.
 - History of ectopic pregnancies.
 - Any genital infection (until successfully treated).
 - Abnormal uterine bleeding of unknown origin.

Trial Summary

Enrollment Goal
2885
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Lanus Oeste, Argentina, 1824

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1425ASQ

Status
Completed
 
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Rosario, Argentina, 2000

Status
Completed
 
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Quebec, Canada, G1V 4X7

Status
Completed
 
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Montreal, Canada, H4P 2S4

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Completed
 
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Sherbrooke, Canada, J1H 4J6

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Completed
 
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Montreal, Canada, H1T 1P6

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Completed
 
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Winnipeg, Canada, R3E 3P4

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Completed
 
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Kingston, Canada, K7L 2V7

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Completed
 
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London, Canada, N6A 4G5

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Completed
 
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Winnipeg, Canada, R3A 1M3

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Completed
 
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Santiago, Chile

Status
Completed
 
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Turku, Finland, 20520

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Completed
 
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Oulu, Finland, 90220

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Completed
 
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Helsinki, Finland, 00100

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Completed
 
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Oulu, Finland, 90100

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Completed
 
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Tampere, Finland, 33100

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Completed
 
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Oulu, Finland, 90570

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Completed
 
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Joensuu, Finland, 80100

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Completed
 
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Kotka, Finland, 48100

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Completed
 
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Turku, Finland, 20100

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Completed
 
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ROANNE, France, 42300

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Completed
 
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Lille, France, 59037

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Completed
 
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REIMS Cedex, France, 51092

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Completed
 
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Le Chesnay, France, 78150

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Completed
 
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Szeged, Hungary, 6720

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Completed
 
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Bekescsaba, Hungary, 5600

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Completed
 
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Eger, Hungary, 3300

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Completed
 
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Nyiregyhaza, Hungary, 4400

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Completed
 
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San Isidro, Argentina, B1642CLN

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Completed
 
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Shawinigan, Canada, G9N 2H6

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Completed
 
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Quebec, Canada, G1S 2L6

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Completed
 
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Saskatoon, Canada, S7H 5M3

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Completed
 
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Waterloo, Canada, N2L 6H6

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Completed
 
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Calgary, Canada, T2N 4L7

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Completed
 
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Santiago de Chile, Chile

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Completed
 
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Helsinki, Finland, 00260

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Completed
 
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Kuopio, Finland, 70110

Status
Completed
 
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Espoo, Finland, 02100

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Completed
 
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Lahti, Finland, 15110

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Completed
 
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Turku, Finland, 20540

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Completed
 
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Nimes, France, 30029

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Completed
 
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Szentes, Hungary, 6600

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Completed
 
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Torreón, Mexico, 27000

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Completed
 
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México, D.F., Mexico, 06700

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Completed
 
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Investigative Site

México, D.F., Mexico, 06720

Status
Terminated
 
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Den Haag, Netherlands, 2545 CH

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Completed
 
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ALKMAAR, Netherlands, 1817 MS

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Completed
 
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ROTTERDAM, Netherlands, 3079 DZ

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Completed
 
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Trondheim, Norway, 7014

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Completed
 
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Kolbotn, Norway, 1411

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Completed
 
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Elverum, Norway, 2403

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Completed
 
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Stockholm, Sweden, 141 86

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Completed
 
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Stockholm, Sweden, 171 76

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Completed
 
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Stockholm, Sweden, 118 83

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Completed
 
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Luleå, Sweden, 972 33

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Completed
 
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Uppsala, Sweden, 75185

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Completed
 
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COMPIEGNE cedex, France, 60204

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Completed
 
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Quetigny, France, 21800

Status
Completed
 
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Grenoble, France, 38043

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Completed
 
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Esztergom, Hungary, 2500

Status
Completed
 
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Investigative Site

Kecskemet, Hungary, 6000

Status
Completed
 
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Budapest, Hungary, 1116

Status
Completed
 
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Hermosillo, Mexico, 83100

Status
Completed
 
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Monterrey, Mexico

Status
Completed
 
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Investigative Site

México, D.F., Mexico, 11000

Status
Terminated
 
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Utrecht, Netherlands, 3582 KE

Status
Completed
 
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Hoofddorp, Netherlands, 2134 TM

Status
Completed
 
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NIJMEGEN, Netherlands, 6532 SZ

Status
Completed
 
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HELMOND, Netherlands, 5707 HA

Status
Completed
 
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Investigative Site

Heerlen, Netherlands, 6419 PC

Status
Completed
 
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Investigative Site

Eindhoven, Netherlands, 5623 EJ

Status
Completed
 
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Investigative Site

Örebro, Sweden, 70185

Status
Completed
 
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Norrköping, Sweden, 602 22

Status
Completed
 
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Malmö, Sweden, 217 44

Status
Completed
 
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Tucson, United States, 85712

Status
Completed
 
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South Bend, United States, 46601

Status
Completed
 
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Columbia, United States, 29201

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Completed
 
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Evansville, United States, 47714

Status
Completed
 
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Boise, United States, 83702

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Completed
 
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Philadelphia, United States, 19114

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Completed
 
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Idaho Falls, United States, 83404

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Completed
 
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Miami, United States, 33186

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Completed
 
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Lincoln, United States, 68510

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Completed
 
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Norfolk, United States, 23507

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Completed
 
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Pittsburgh, United States, 15206

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Completed
 
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San Diego, United States, 92103

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Completed
 
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Oslo, Norway, 0364

Status
Completed
 
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Larvik, Norway, 3264

Status
Completed
 
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Stockholm, Sweden, 182 88

Status
Completed
 
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Umeå, Sweden, 90185

Status
Completed
 
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Göteborg, Sweden, 416 64

Status
Completed
 
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Investigative Site

San Diego, United States, 92108

Status
Completed
 
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Investigative Site

Boyton Beach, United States, 33472

Status
Completed
 
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Investigative Site

Jenkintown, United States, 19046

Status
Completed
 
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Investigative Site

Carmichael, United States, 95608

Status
Completed
 
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Medford, United States, 97504

Status
Completed
 
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West Palm Beach, United States, 33409

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Completed
 
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Chattanooga, United States, 37404

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Completed
 
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Kalamazoo, United States, 49009

Status
Completed
 
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Investigative Site

Atlanta, United States, 30328

Status
Completed
 
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Investigative Site

Pacific Palisades, United States, 90272

Status
Completed
 
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Investigative Site

Mobile, United States, 36608

Status
Completed
 
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Investigative Site

Portland, United States, 97239

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Completed
 
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Moorestown, United States, 08057

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Completed
 
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Investigative Site

Las Vegas, United States, 89106

Status
Completed
 
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Investigative Site

Las Vegas, United States, 89135

Status
Completed
 
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Investigative Site

San Diego, United States, 92123

Status
Completed
 
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Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
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Investigative Site

Memphis, United States, 38119

Status
Completed
 
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Investigative Site

Chicago, United States, 60612

Status
Completed
 
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Investigative Site

Phoenix, United States, 85032

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45267

Status
Completed
 
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Investigative Site

Albuquerque, United States, 87102

Status
Completed
 
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Investigative Site

Glendale, United States, 85304

Status
Completed
 
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Investigative Site

New York, United States, 10032

Status
Completed
 
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Investigative Site

San Diego, United States, 92130

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32216

Status
Completed
 
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Investigative Site

Seattle, United States, 98105

Status
Completed
 
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Investigative Site

Spokane, United States, 99207

Status
Completed
 
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Investigative Site

New Bern, United States, 28562

Status
Completed
 
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Investigative Site

Chesterfield, United States, 63017

Status
Completed
 
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Investigative Site

Marrero, United States, 70072

Status
Completed
 
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Investigative Site

Houston, United States, 77030

Status
Completed
 
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Investigative Site

Littleton, United States, 80128

Status
Completed
 
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Investigative Site

Denver, United States, 80218

Status
Completed
 
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Investigative Site

Boston, United States, 02118

Status
Completed
 
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Investigative Site

Nashville, United States, 37203

Status
Completed
 
Locations

Investigative Site

Torrance, United States, 90502

Status
Completed
 
Locations

Investigative Site

New Brunswick, United States, 08903-2685

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15213-3180

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89128

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77054

Status
Completed
 
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Investigative Site

Chaska, United States, 55318

Status
Completed
 
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Investigative Site

Columbus, United States, 43213

Status
Completed
 
Locations

Investigative Site

Austin, United States, 78748

Status
Completed
 
Locations

Investigative Site

Decatur, United States, 30034

Status
Completed
 

Trial Design