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NCT03587805CompletedPhase 3

Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND

An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

Source: ClinicalTrials.gov · Last updated 11 Mar 2025

Brief summary (registry, in English)

The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1672 (actual)
First submitted
3 Jul 2018
Start date
18 Mar 2018
Primary completion date
3 Jul 2024
Lead sponsor
LEO Pharma
NCT number
NCT03587805
EudraCT number
2018-000746-19

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1672
  • From 18 Mar 2018 to the primary completion date, 3 Jul 2024
  • 241 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
  • Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
  • Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
  • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
  • Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
  • Clinically significant infection within 4 weeks prior to baseline.
  • A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
  • Tuberculosis requiring treatment within 12 months prior to screening.

Other illness

  • Any condition that required permanent discontinuation of trial treatment in the parent trial.
  • Known primary immunodeficiency disorder.

Who the study is looking for

  • Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
  • Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
  • Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
  • Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (241)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BrusselsBelgiumUnknown status
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EdegemBelgiumUnknown status
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GhentBelgiumUnknown status
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HerstalBelgiumUnknown status
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KortrijkBelgiumUnknown status
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LeuvenBelgiumUnknown status
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LiègeBelgiumUnknown status
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LovervalBelgiumUnknown status
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MaldegemBelgiumUnknown status
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AjaxCanadaUnknown status
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BathurstCanadaUnknown status
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CalgaryCanadaUnknown status
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EdmontonCanadaUnknown status
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EtobicokeCanadaUnknown status
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FrederictonCanadaUnknown status
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HalifaxCanadaUnknown status
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HamiltonCanadaUnknown status
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LondonCanadaUnknown status
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MarkhamCanadaUnknown status
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MississaugaCanadaUnknown status
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MontrealCanadaUnknown status
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North BayCanadaUnknown status
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OakvilleCanadaUnknown status
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OttawaCanadaUnknown status
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PeterboroughCanadaUnknown status
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QuébecCanadaUnknown status
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Richmond HillCanadaUnknown status
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SaskatoonCanadaUnknown status
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St. John'sCanadaUnknown status
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SurreyCanadaUnknown status
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TorontoCanadaUnknown status
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VancouverCanadaUnknown status
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VerdunCanadaUnknown status
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WaterlooCanadaUnknown status
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WindsorCanadaUnknown status
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WinnipegCanadaUnknown status
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Karlovy VaryCzechiaUnknown status
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Kutná HoraCzechiaUnknown status
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Ostrava-PorubaCzechiaUnknown status
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PardubiceCzechiaUnknown status
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PragueCzechiaUnknown status
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AachenGermanyUnknown status
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AugsburgGermanyUnknown status
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Bad BentheimGermanyUnknown status
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BerlinGermanyUnknown status
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BielefeldGermanyUnknown status
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BochumGermanyUnknown status
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BonnGermanyUnknown status
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DarmstadtGermanyUnknown status
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DresdenGermanyUnknown status
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DülmenGermanyUnknown status
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ErlangenGermanyUnknown status
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Frankfurt am MainGermanyUnknown status
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FriedrichshafenGermanyUnknown status
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GeraGermanyUnknown status
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HalleGermanyUnknown status
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HamburgGermanyUnknown status
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HanoverGermanyUnknown status
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JenaGermanyUnknown status
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KielGermanyUnknown status
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LeipzigGermanyUnknown status
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MainzGermanyUnknown status
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MünchenGermanyUnknown status
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MünsterGermanyUnknown status
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OsnabrückGermanyUnknown status
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SeltersGermanyUnknown status
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TübingenGermanyUnknown status
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AlicanteSpainUnknown status
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BadalonaSpainUnknown status
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BarakaldoSpainUnknown status
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BarcelonaSpainUnknown status
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BilbaoSpainUnknown status
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CórdobaSpainUnknown status
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FuenlabradaSpainUnknown status
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GranadaSpainUnknown status
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L'Hospitalet de LlobregatSpainUnknown status
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MadridSpainUnknown status
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PamplonaSpainUnknown status
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PontevedraSpainUnknown status
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SevilleSpainUnknown status
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ValenciaSpainUnknown status
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BordeauxFranceUnknown status
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DijonFranceUnknown status
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GrenobleFranceUnknown status
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LilleFranceUnknown status
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MarseilleFranceUnknown status
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MartiguesFranceUnknown status
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MulhouseFranceUnknown status
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NiceFranceUnknown status
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ParisFranceUnknown status
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Pierre-BéniteFranceUnknown status
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RouenFranceUnknown status
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Saint-EtienneFranceUnknown status
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ToulouseFranceUnknown status
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ValenceFranceUnknown status
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BirminghamUnited KingdomUnknown status
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CambridgeUnited KingdomUnknown status
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CottinghamUnited KingdomUnknown status
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DudleyUnited KingdomUnknown status
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DundeeUnited KingdomUnknown status
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HarlowUnited KingdomUnknown status
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HarrogateUnited KingdomUnknown status
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LeytonstoneUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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RedhillUnited KingdomUnknown status
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SalfordUnited KingdomUnknown status
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SheffieldUnited KingdomUnknown status
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SouthamptonUnited KingdomUnknown status
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WakefieldUnited KingdomUnknown status
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WalsallUnited KingdomUnknown status
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BresciaItalyUnknown status
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CataniaItalyUnknown status
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L’AquilaItalyUnknown status
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RomaItalyUnknown status
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RozzanoItalyUnknown status
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AsahikawaJapanUnknown status
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Chikushino-shiJapanUnknown status
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ChūōkuJapanUnknown status
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FukuokaJapanUnknown status
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FukushimaJapanUnknown status
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GifuJapanUnknown status
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HamamatsuJapanUnknown status
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HyōgoJapanUnknown status
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Ichikawa-shiJapanUnknown status
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IchinomiyaJapanUnknown status
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KagoshimaJapanUnknown status
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Kawasaki-shiJapanUnknown status
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Koto-KuJapanUnknown status
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KyotoJapanUnknown status
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Minato-KuJapanUnknown status
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MoriokaJapanUnknown status
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NagoyaJapanUnknown status
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Nonoichi-shiJapanUnknown status
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ObihiroJapanUnknown status
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OsakaJapanUnknown status
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OsakaJapanUnknown status
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OsakaJapanUnknown status
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SapporoJapanUnknown status
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Setagaya-kuJapanUnknown status
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Shimotsuke-shiJapanUnknown status
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Shinjuku-KuJapanUnknown status
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TokyoJapanUnknown status
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ToyamaJapanUnknown status
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Toyonaka-shiJapanUnknown status
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YokohamaJapanUnknown status
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BialystokPolandUnknown status
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BochniaPolandUnknown status
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BydgoszczPolandUnknown status
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GdanskPolandUnknown status
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GdyniaPolandUnknown status
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KatowicePolandUnknown status
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KrakowPolandUnknown status
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LodzPolandUnknown status
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LublinPolandUnknown status
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PoznanPolandUnknown status
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RzeszówPolandUnknown status
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WarsawPolandUnknown status
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WroclawPolandUnknown status
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AlbanyUnited StatesUnknown status
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Ann ArborUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BakersfieldUnited StatesUnknown status
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BangorUnited StatesUnknown status
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Baton RougeUnited StatesUnknown status
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BellaireUnited StatesUnknown status
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Beverly HillsUnited StatesUnknown status
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BexleyUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BrightonUnited StatesUnknown status
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BuffaloUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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ClarksvilleUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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CortlandUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DetroitUnited StatesUnknown status
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DoralUnited StatesUnknown status
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DublinUnited StatesUnknown status
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East WindsorUnited StatesUnknown status
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EncinitasUnited StatesUnknown status
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FairbornUnited StatesUnknown status
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Fort SmithUnited StatesUnknown status
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Fountain ValleyUnited StatesUnknown status
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FremontUnited StatesUnknown status
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FriscoUnited StatesUnknown status
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FullertonUnited StatesUnknown status
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GoodlettsvilleUnited StatesUnknown status
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HendersonUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HorseheadsUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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Kew GardensUnited StatesUnknown status
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Lake CharlesUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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MaconUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MissoulaUnited StatesUnknown status
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MobileUnited StatesUnknown status
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MorgantownUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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NewnanUnited StatesUnknown status
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Newport BeachUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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NorfolkUnited StatesUnknown status
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North CharlestonUnited StatesUnknown status
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North Miami BeachUnited StatesUnknown status
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NorthridgeUnited StatesUnknown status
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Orange ParkUnited StatesUnknown status
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Overland ParkUnited StatesUnknown status
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Palo AltoUnited StatesUnknown status
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PflugervilleUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PlainfieldUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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QuincyUnited StatesUnknown status
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RaleighUnited StatesUnknown status
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Saint JosephUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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San Luis ObispoUnited StatesUnknown status
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Santa AnaUnited StatesUnknown status
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Santa MonicaUnited StatesUnknown status
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SavannahUnited StatesUnknown status
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South BurlingtonUnited StatesUnknown status
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SweetwaterUnited StatesUnknown status
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TampaUnited StatesUnknown status
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ToledoUnited StatesUnknown status
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TroyUnited StatesUnknown status
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TulsaUnited StatesUnknown status
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WebsterUnited StatesUnknown status
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West BloomfieldUnited StatesUnknown status
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West Palm BeachUnited StatesUnknown status
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YpsilantiUnited StatesUnknown status

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