A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Last updated: November 7, 2025
Sponsor: Insmed Incorporated
Overall Status: Completed

Phase

2

Condition

Sinusitis

Sinus Infections

Soft Tissue Infections

Treatment

Placebo

Brensocatib

Mometasone furoate nasal spray (MFNS)

Clinical Study ID

NCT06013241
INS1007-221
2022-502481-24-00
  • Ages 18-75
  • All Genders

Study Summary

The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who have at least a 12-week history before Screening Visit of CRSsNPand confirmed by endoscopy at Visit 1 (Screening).

  • Participants must have a NCS of ≥2 at Visit 1 (Screening Visit) and Visit 2 (Baseline; average score in the week prior to randomization).

  • Participants must have sTSS (nasal congestion [NC], anterior/posterior rhinorrhea,facial pain/pressure) ≥5 at Visit 1 (Screening) and at Visit 2 (Baseline; averagescore in the week prior to randomization).

  • Participants who have at least 1 of the 3 following features:

  1. Previous sinonasal surgery for CRS, including but not limited to fenestratedendoscopic sinus surgery and balloon sinuplasty.

  2. Received medical treatment with systemic corticosteroids (SCS) to treatsymptoms of CRS as defined by any dose and duration within 1 year of ScreeningVisit or intolerance/contraindication to SCS.

  3. Received a course of antibiotics to treat symptoms of CRS within 1 year beforethe Screening Visit.

  • Participants who have a blood eosinophil count ≤750 cells/microliter (μL) at Visit 1 (Screening).

  • Participants who have bilateral inflammation of paranasal sinuses in the CT scanperformed during Screening and bilateral ethmoid and/or maxillary opacificationbefore randomization as confirmed by the central reader.

  • Participants who have a SNOT-22 score of ≥20 at Visit 1 (Screening) and Visit 2 (Baseline).

  • Participants who have received a stable daily dose regimen of MFNS for at least 4weeks before Visit 2 (Baseline).

Exclusion

Exclusion Criteria:

  • Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps (CRSwNP).

  • Clinical diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia.

  • Scheduled sinus surgery at any time during the study.

  • Participants who have had nasal surgery within 4 weeks before Visit 1 (Screening)and during the Screening Period.

  • Significant oral maxillofacial structural abnormalities or severe septal deviation.

  • Participants with radiological suspicion or confirmed invasive fungalrhinosinusitis, odontogenic sinusitis, osteomas, or nasal tumors.

  • Participants with acute change in symptoms consistent with acute rhinosinusitis.

  • Participants with seasonal allergic rhinitis whose symptoms coincide with thetreatment period of the study.

  • Participants with moderate to severe atopic dermatitis requiring treatment with highpotency topical steroids or topical calcineurin inhibitors or biologics.

  • Clinical diagnosis of Papillon-Lefèvre syndrome.

Note: Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 288
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 30, 2023
Estimated Completion Date:
October 30, 2025

Connect with a study center

  • ARG001

    La Plata, Buenos Aires B1900
    Argentina

    Site Not Available

  • ARG015

    La Plata, Buenos Aires B1900BNN
    Argentina

    Site Not Available

  • ARG006

    Lobos, Buenos Aires B7240AAN
    Argentina

    Site Not Available

  • ARG001

    La Plata 3432043, Buenos Aires 3435907 B1900
    Argentina

    Site Not Available

  • ARG015

    La Plata 3432043, Buenos Aires 3435907 B1900BNN
    Argentina

    Site Not Available

  • ARG006

    Lobos 3431313, Buenos Aires 3435907 B7240AAN
    Argentina

    Site Not Available

  • ARG005

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1121ABE
    Argentina

    Site Not Available

  • ARG011

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1425
    Argentina

    Site Not Available

  • ARG012

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1414
    Argentina

    Site Not Available

  • ARG017

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1426ABP
    Argentina

    Site Not Available

  • ARG005

    Buenos Aires 3435910, Ciudad Autónoma de BuenosAires C1121ABE
    Argentina

    Site Not Available

  • ARG011

    Buenos Aires 3435910, Ciudad Autónoma de BuenosAires C1425
    Argentina

    Site Not Available

  • ARG012

    Buenos Aires 3435910, Ciudad Autónoma de BuenosAires C1414
    Argentina

    Site Not Available

  • ARG017

    Buenos Aires 3435910, Ciudad Autónoma de BuenosAires C1426ABP
    Argentina

    Site Not Available

  • ARG013

    San Rafael, Mendoza M5600IBJ
    Argentina

    Site Not Available

  • ARG013

    San Rafael 3836669, Mendoza Province 3844419 M5600IBJ
    Argentina

    Site Not Available

  • ARG004

    Rosario, Santa Fe S2013
    Argentina

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  • ARG007

    Rosario, Santa Fe S2013DBS
    Argentina

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  • ARG010

    Rosario, Santa Fe S2013DTC
    Argentina

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  • ARG004

    Rosario 3838583, Santa Fe Province 3836276 S2013
    Argentina

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  • ARG007

    Rosario 3838583, Santa Fe Province 3836276 S2013DBS
    Argentina

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  • ARG010

    Rosario 3838583, Santa Fe Province 3836276 S2013DTC
    Argentina

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  • ARG009

    San Miguel De Tucumán, Tucumán T4000AXL
    Argentina

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  • ARG009

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000AXL
    Argentina

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  • ARG002

    Mar del Plata, B7602DCK
    Argentina

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  • ARG002

    Mar del Plata 3430863, B7602DCK
    Argentina

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  • ARG003

    Mendoza, M5500CCG
    Argentina

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  • ARG014

    Mendoza, 5500
    Argentina

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  • ARG003

    Mendoza 3844421, M5500CCG
    Argentina

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  • ARG014

    Mendoza 3844421, 5500
    Argentina

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  • ARG016

    Rosario, S2002KDT
    Argentina

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    Rosario 3838583, S2002KDT
    Argentina

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  • ARG008

    Santa Fe, 3000
    Argentina

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    Santa Fe 3836277, 3000
    Argentina

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  • AUS004

    Birtinya, Queensland 4575
    Australia

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  • AUS001

    Herston, Queensland 4029
    Australia

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    Herston 6931014, Queensland 2152274 4029
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  • AUS003

    Melbourne, Victoria 3000
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  • AUS002

    Spearwood, Western Australia 6163
    Australia

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  • AUS002

    Spearwood 2061224, Western Australia 2058645 6163
    Australia

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  • BEL002

    Faulx-les-Tombes, Namur 5340
    Belgium

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    Faux-Les-Tombes, Namur 5340
    Belgium

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  • BEL001

    Gent, Oost-Vlaanderen 9000
    Belgium

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  • BEL001

    Ghent 2797656, Oost-Vlaanderen 9000
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  • BEL002

    Erpent, 5101
    Belgium

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    Erpent 2798674, 5101
    Belgium

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    Sint-Lambrechts-Woluwe, 1200
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    Woluwe-Saint-Lambert, 1200
    Belgium

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    Woluwe-Saint-Lambert 2783476, 1200
    Belgium

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    Sofia, Sofia-Grad 1527
    Bulgaria

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    Sofia, Sofia-Grad 1606
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    Sofia 727011, Sofia-Grad 731061 1606
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    Plovdiv, 4001
    Bulgaria

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    Plovdiv 728193, 4001
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    Stara Zagora, 6003
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    Stara Zagora, 6000
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    Stara Zagora 726848, 6000
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  • CAN003

    Vancouver, British Columbia V6Z 1Y6
    Canada

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    Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
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    London, Ontario N6A 4V2
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    Toronto, Ontario M5G 1X5
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    London 6058560, Ontario 6093943 N6A 4V2
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    Toronto 6167865, Ontario 6093943 M5G 1X5
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    Montreal, Quebec H4A 3J1
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    Quebec City, Quebec G1S 4L8
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    Montreal 6077243, Quebec 6115047 H4A 3J1
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    Québec 6325494, Quebec 6115047 G1S 4L8
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    Quebec, G1V 4W2
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    Québec 6325494, G1V 4W2
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  • CZE002

    Olomouc, Olomoucký Kraj 779 00
    Czechia

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    Olomouc 3069011, Olomoucký kraj 3339542 779 00
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  • CZE003

    Pardubice, Pardubický Kraj 532 03
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    Pardubice 3068582, Pardubický kraj 3339574 532 03
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  • CZE005

    Nový Hradec Králové, 500 05
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    Nový Hradec Králové 3069310, 500 05
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    Prague, 140 59
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    Prague 3067696, 140 59
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    Hillerød, Capital 3400
    Denmark

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    Hillerød 2620320, Capital 3400
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    København Ø, Capital 2100
    Denmark

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    København Ø 11746747, Capital 2100
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  • DNK003

    Aarhus C, Central Jutland 8000
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    Aarhus C 11746746, Central Jutland 6418539 8000
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    Køge, Zeeland 4600
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    Køge 2618415, Zeeland 4600
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  • FRA002

    Strasbourg, Bas-Rhin 67200
    France

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    Strasbourg 2973783, Bas-Rhin 67200
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  • FRA003

    Marseille, Bouches-du-Rhône 13010
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  • FRA003

    Marseille 2995469, Bouches-du-Rhône 13010
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  • FRA001

    Nantes, Loire-Atlantique 44000
    France

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  • FRA001

    Nantes 2990969, Loire-Atlantique 44000
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  • FRA004

    La Roche-sur-Yon, Vendée 85925
    France

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  • FRA004

    La Roche-sur-Yon 3006767, Vendée 85925
    France

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  • GER004

    Wiesbaden 2809346, Hesse 2905330 65183
    Germany

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  • GER004

    Wiesbaden, Hessen 65183
    Germany

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  • GER009

    Leipzig, Sachsen 04103
    Germany

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  • GER003

    Mittweida, Sachsen 09648
    Germany

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  • GER009

    Leipzig 2879139, Saxony 2842566 04103
    Germany

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  • GER003

    Mittweida 2870318, Saxony 2842566 09648
    Germany

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  • GER008

    Lübeck, Schleswig-Holstein 23562
    Germany

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  • GER008

    Lübeck 2875601, Schleswig-Holstein 2838632 23562
    Germany

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  • GER005

    Jena 2895044, Thuringia 2822542 07747
    Germany

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  • GER005

    Jena, Thüringen 07747
    Germany

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  • GER007

    Berlin, 10117
    Germany

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  • GER007

    Berlin 2950159, 10117
    Germany

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  • GER001

    Dresden, 01307
    Germany

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  • GER001

    Dresden 2935022, 01307
    Germany

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  • HUN003

    Pécs, Baranya 7621
    Hungary

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  • HUN003

    Pécs 3046526, Baranya 3055399 7621
    Hungary

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  • ITA001

    Rozzano, Lombardia 20089
    Italy

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  • ITA001

    Rozzano 3168837, Lombardy 3174618 20089
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  • ITA002

    Sassari, Sardegna 07100
    Italy

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  • ITA002

    Sassari 3167096, Sardinia 2523228 07100
    Italy

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  • ITA003

    Pisa, Toscana 56124
    Italy

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  • ITA004

    Siena, Toscana 53100
    Italy

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  • ITA003

    Pisa 3170647, Tuscany 3165361 56124
    Italy

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  • POL009

    Wroclaw, Dolnoslaskie 52-416
    Poland

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  • POL002

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-309
    Poland

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  • POL010

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-693
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  • POL005

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-033
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  • POL007

    Wieliczka 755889, Lesser Poland Voivodeship 858786 32-020
    Poland

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  • POL009

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-416
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  • POL003

    Lublin, Lubelskie 20-954
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  • POL003

    Lublin 765876, Lublin Voivodeship 858785 20-954
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  • POL005

    Kraków, Malopolskie 30-033
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  • POL007

    Wieliczka, Malopolskie 32-020
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  • POL001

    Warsaw 756135, Masovian Voivodeship 858787 00-189
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  • POL001

    Warszawa, Mazowieckie 00-189
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  • POL004

    Białystok, Podlaskie 15-276
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  • POL004

    Bialystok 776069, Podlaskie Voivodeship 858789 15-276
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  • POL006

    Katowice 3096472, Silesian Voivodeship 3337497 40-611
    Poland

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  • POL006

    Katowice, Slaskie 40-611
    Poland

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  • POL002

    Poznan, Wielkopolskie 60-309
    Poland

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  • POL010

    Poznan, Wielkopolskie 60-693
    Poland

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  • POL008

    Warsaw 756135, 04-141
    Poland

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  • POL008

    Warszawa, 04-141
    Poland

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  • PRT001

    Guimarães, Braga 4835-044
    Portugal

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  • PRT001

    Guimarães 2738752, Braga District 2742031 4835-044
    Portugal

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  • PRT003

    Lisbon, Lisboa 1349-019
    Portugal

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  • PRT003

    Lisbon 2267057, Lisbon District 2267056 1349-019
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  • PRT005

    Senhora Da Hora, Porto 4464-513
    Portugal

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  • PRT005

    Senhora da Hora 2734140, Porto District 2735941 4464-513
    Portugal

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  • PRT004

    Aveiro, 3814-501
    Portugal

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  • PRT004

    Aveiro 2742611, 3814-501
    Portugal

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  • PRT002

    Braga, 4710
    Portugal

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  • PRT002

    Braga 2742032, 4710
    Portugal

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  • ESP003

    Santander, Cantabria 39008
    Spain

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  • ESP003

    Santander 3109718, Cantabria 3336898 39008
    Spain

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  • ESP002

    Jerez de la Frontera, Cádiz 11407
    Spain

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  • ESP002

    Jerez de la Frontera 2516326, Cádiz 11407
    Spain

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  • ESP004

    Malaga, Málaga 29009
    Spain

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  • ESP004

    Málaga 2514256, Málaga 29009
    Spain

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  • ESP001

    Sevilla, 41009
    Spain

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  • ESP001

    Seville 2510911, 41009
    Spain

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  • USA034

    Tucson, Arizona 85704
    United States

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  • USA034

    Tucson 5318313, Arizona 5551752 85704
    United States

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  • USA002

    Roseville, California 95661
    United States

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  • USA006

    Upland, California 91786
    United States

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  • USA002

    Roseville 5388881, California 5332921 95661
    United States

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  • USA006

    Upland 5404915, California 5332921 91786
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  • USA010

    Colorado Springs, Colorado 80909-1177
    United States

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  • USA016

    Boca Raton, Florida 33487
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  • USA019

    Hollywood, Florida 33024
    United States

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  • USA001

    Miami, Florida 33135
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  • USA009

    Tampa, Florida 33613
    United States

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  • USA016

    Boca Raton 4148411, Florida 4155751 33487
    United States

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  • USA019

    Hollywood 4158928, Florida 4155751 33024
    United States

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  • USA001

    Miami 4164138, Florida 4155751 33135
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  • USA009

    Tampa 4174757, Florida 4155751 33613
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  • USA021

    Chicago, Illinois 60612
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  • USA031

    Chicago, Illinois 60611
    United States

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  • USA036

    Chicago, Illinois 60657
    United States

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  • USA021

    Chicago 4887398, Illinois 4896861 60612
    United States

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  • USA031

    Chicago 4887398, Illinois 4896861 60611
    United States

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  • USA003

    New Albany, Indiana 47150
    United States

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  • USA003

    New Albany 4262045, Indiana 4921868 47150
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  • USA035

    Mandeville, Louisiana 70471
    United States

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  • USA035

    Mandeville 4332455, Louisiana 4331987 70471
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  • USA026

    Baltimore, Maryland 21287
    United States

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  • USA026

    Baltimore 4347778, Maryland 4361885 21287
    United States

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  • USA011

    Columbia, Missouri 65212
    United States

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  • USA024

    Saint Louis, Missouri 63141
    United States

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  • USA011

    Columbia 4381982, Missouri 4398678 65212
    United States

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  • USA024

    St Louis 4407066, Missouri 4398678 63141
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  • USA033

    New York, New York 10016
    United States

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  • USA033

    New York 5128581, New York 5128638 10016
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  • USA004

    Tulsa, Oklahoma 74136
    United States

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  • USA028

    Tulsa, Oklahoma 74132
    United States

    Site Not Available

  • USA004

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

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  • USA028

    Tulsa 4553433, Oklahoma 4544379 74132
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  • USA015

    Hershey, Pennsylvania 17033
    United States

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  • USA015

    Hershey 5193342, Pennsylvania 6254927 17033
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  • USA023

    Charleston, South Carolina 29425
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    North Charleston, South Carolina 29406
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  • USA023

    Charleston 4574324, South Carolina 4597040 29425
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  • USA022

    North Charleston 4589387, South Carolina 4597040 29406
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  • USA025

    Dallas, Texas 75231
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  • USA037

    Fredericksburg, Texas 78624
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  • USA018

    Houston, Texas 77030
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  • USA029

    Houston, Texas 77022
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  • USA030

    San Antonio, Texas 78258
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  • USA038

    Tomball, Texas 77375
    United States

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  • USA025

    Dallas 4684888, Texas 4736286 75231
    United States

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  • USA037

    Fredericksburg 4692279, Texas 4736286 78624
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  • USA018

    Houston 4699066, Texas 4736286 77030
    United States

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  • USA029

    Houston 4699066, Texas 4736286 77022
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  • USA030

    San Antonio 4726206, Texas 4736286 78258
    United States

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  • USA038

    Tomball 4737094, Texas 4736286 77375
    United States

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  • USA005

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • USA005

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

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