An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.

Last updated: August 28, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

2

Condition

Bronchiectasis

Lung Disease

Chronic Bronchitis

Treatment

Placebo

Mitiperstat (AZD4831)

Clinical Study ID

NCT05492877
D6582C00001
2022-002441-18
  • Ages 40-80
  • All Genders

Study Summary

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of informed consent.

  • Participants must be deemed as high risk of exacerbations as defined by: >= 1moderate or severe exacerbation in the previous 24 months; or frequent productivecough; or post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) < 50% predicted.

  • Participants must be 40-80 years of age inclusive, at the time of signing informedconsent form (ICF).

  • Participants who have a confirmed primary diagnosis of moderate to severe COPD.

  • Participants who are current or ex-smokers with a tobacco history of ≥ 10pack-years.

  • Participants who have a documented stable regimen of triple therapy or dual therapyfor

≥ 3 months prior to enrolment.

  • Body mass index within the range 18 to 40 kg/m2 (inclusive).

Exclusion

Exclusion Criteria:

  • As judged by the investigator, any evidence of any active medical or psychiatriccondition or other reason (at SV1 [screening] and SV3 [pre-dose]) which in theinvestigator's opinion makes it undesirable for the participant to participate inthe study.

  • Current diagnosis of asthma or past diagnosis of asthma which persisted beyond theage of 25 years.

  • Clinically important pulmonary disease other than COPD.

  • Any other clinically relevant abnormal findings on physical examination, laboratorytesting including haematology, coagulation, serum chemistry, or urinalysis; or chestCT scan at screening or randomisation, which in the opinion of the investigator ormedical monitor may compromise the safety of the participant in the study orinterfere with evaluation of the study intervention or reduce the participant'sability to participate in the study.

  • History of a clinically significant infection (viral, bacterial, or fungal; definedas requiring systemic antibiotics, antiviral, or antifungal medication for > 7 days)within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinicalsuspicion of infection at time of dosing.

Study Design

Total Participants: 381
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 14, 2022
Estimated Completion Date:
August 12, 2024

Study Description

Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease.

Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.

Connect with a study center

  • Research Site

    Buenos Aires, C1121ABE
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires 3435910, C1425BEN
    Argentina

    Site Not Available

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    Córdoba, X5003DCE
    Argentina

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    Córdoba 3860259, X5003DCE
    Argentina

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    Ranelagh, 1886
    Argentina

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    Ranelagh 3429604, 1886
    Argentina

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    San Fernando, B1646EBJ
    Argentina

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    San Fernando 3429095, B1646EBJ
    Argentina

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    Dupnitsa, 2602
    Bulgaria

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    Dupnitsa 726872, 2602
    Bulgaria

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    Haskovo, 6305
    Bulgaria

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    Haskovo 730435, 6305
    Bulgaria

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    Pernik, 2300
    Bulgaria

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    Pernik 728330, 2300
    Bulgaria

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    Rousse 727523, 7000
    Bulgaria

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    Ruse, 7000
    Bulgaria

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    Sofia, 1756
    Bulgaria

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    Sofia 727011, 1756
    Bulgaria

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    Stara Zagora, 6000
    Bulgaria

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    Stara Zagora 726848, 6000
    Bulgaria

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    Vratsa, 3000
    Bulgaria

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    Vratsa 725712, 3000
    Bulgaria

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    Calgary, Alberta T3B 0M3
    Canada

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    Calgary 5913490, Alberta 5883102 T3B 0M3
    Canada

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    Montreal, Quebec H1M 1B1
    Canada

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    Montréal, Quebec H1M 1B1
    Canada

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    St Charles Borromee, Quebec J6E 2B4
    Canada

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    Trois-Rivières, Quebec G8T 7A1
    Canada

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    Québec 6325494, Quebec 6115047 G3K 2P8
    Canada

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    Saint-Charles-Borromée 6137579, Quebec 6115047 J6E 2B4
    Canada

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    Trois-Rivières 6169141, Quebec 6115047 G8T 7A1
    Canada

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    Quebec, G3K 2P8
    Canada

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    Aalborg, 9000
    Denmark

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    Aalborg 2624886, 9000
    Denmark

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    Hvidovre, 2650
    Denmark

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    Hvidovre 2619528, 2650
    Denmark

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    København NV, 2400
    Denmark

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    København NV 11746894, 2400
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    Næstved, 4700
    Denmark

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    Næstved 2616038, 4700
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    Odense C, 5000
    Denmark

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    Odense C 11746507, 5000
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    Vejle, 7100
    Denmark

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    Vejle 2610613, 7100
    Denmark

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    Berlin, 10119
    Germany

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    Berlin 2950159, 10119
    Germany

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    Frankfurt, 60596
    Germany

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    Frankfurt 2925536, 60596
    Germany

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    Frankfurt am Main, 60596
    Germany

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    Hamburg, 22299
    Germany

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    Hannover, D-30173
    Germany

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    Homburg, 66421
    Germany

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    Immenhausen, 34376
    Germany

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    Immenhausen 2896279, 34376
    Germany

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    Koblenz, 56068
    Germany

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    Koblenz 2886946, 56068
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    Landsberg, 86899
    Germany

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    Landsberg 2881508, 86899
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    Leipzig, 04299
    Germany

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    Leipzig 2879139, 04299
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    Marburg, 35037
    Germany

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    Marburg 2873759, 35037
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    Witten, 58452
    Germany

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    Witten 2807363, 58452
    Germany

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    Foggia, 71100
    Italy

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    Foggia 3176885, 71100
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    Roma, 00168
    Italy

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    Roma 8957247, 00168
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    Sassari, 07100
    Italy

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    Sassari 3167096, 07100
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    Siena, 53100
    Italy

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    Siena 3166548, 53100
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    Verona, 37134
    Italy

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    Verona 3164527, 37134
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    Culiacán, 80200
    Mexico

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    Culiacán 4012176, 80200
    Mexico

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    Guadalajara, 44100
    Mexico

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    Guadalajara 4005539, 44670
    Mexico

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    Mexico City, 3103
    Mexico

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    Monterrey, 64310
    Mexico

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    Monterrey 3995465, 64465
    Mexico

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    Veracruz, 91910
    Mexico

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    Veracruz 3514783, 91910
    Mexico

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    Zapopan, 45138
    Mexico

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    Zapopan 3979770, 45138
    Mexico

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    Groningen, 9713 GH
    Netherlands

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    Groningen 2755251, 9713 GH
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    Rotterdam, 3045 PM
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    Veldhoven, 5504 DB
    Netherlands

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    Veldhoven 2745706, 5504 DB
    Netherlands

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    Bielsko-Biala 3103402, 43-300
    Poland

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    Bielsko-Biała, 43-300
    Poland

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    Chęciny, 26-060
    Poland

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    Chęciny 774572, 26-060
    Poland

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    Karczew, 05-480
    Poland

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    Karczew 769539, 05-480
    Poland

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    Krakow 3094802, 31-011
    Poland

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    Kraków, 31-011
    Poland

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    Ksawerów, 95-054
    Poland

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    Ksawerów 3094370, 95-054
    Poland

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    Proszowice, 32-100
    Poland

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    Sosnowiec, 41-200
    Poland

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    Staszów, 28-200
    Poland

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    Staszów 758252, 28-200
    Poland

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    Szczecin, 70-111
    Poland

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    Szczecin 3083829, 70-111
    Poland

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  • Research Site

    Trzebnica, 55-100
    Poland

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    Warsaw 756135, 01-456
    Poland

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    Warszawa, 01-456
    Poland

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  • Research Site

    Cape Town, 7700
    South Africa

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    Cape Town 3369157, 7700
    South Africa

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    Durban, 4093
    South Africa

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    Durban 1007311, 4093
    South Africa

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    Krugersdorp, 1739
    South Africa

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  • Research Site

    Lenasia, 1827
    South Africa

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    Tygervalley, 7530
    South Africa

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    Vereeniging, 1935
    South Africa

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  • Research Site

    Vereeniging 944385, 1935
    South Africa

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    Granada, 18014
    Spain

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    Granada 2517117, 18014
    Spain

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    Madrid, 28007
    Spain

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    Madrid 3117735, 28007
    Spain

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    Merida, 06800
    Spain

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  • Research Site

    Málaga, 29010
    Spain

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    Málaga 2514256, 29010
    Spain

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    Mérida, 06800
    Spain

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    Mérida 2513917, 06800
    Spain

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    Santander, 39008
    Spain

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    Santander 3109718, 39008
    Spain

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    Adana, 01330
    Turkey

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    Ankara, 06620
    Turkey

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    Istanbul, 34854
    Turkey

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    Izmir, 35360
    Turkey

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    Mersin, 33343
    Turkey

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    Adana 325363, 01330
    Turkey (Türkiye)

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    Ankara 323786, 06620
    Turkey (Türkiye)

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    Istanbul 745044, 34890
    Turkey (Türkiye)

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    Izmir 311046, 35360
    Turkey (Türkiye)

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    Mersin 304531, 33343
    Turkey (Türkiye)

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  • Research Site

    Bradford, BD9 6RJ
    United Kingdom

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    Bradford 2654993, BD9 6RJ
    United Kingdom

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    Cambridge, CB2 0QQ
    United Kingdom

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    Cambridge 2653941, CB2 0QQ
    United Kingdom

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    Cottingham, HU16 5JQ
    United Kingdom

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    Cottingham 2652263, HU16 5JQ
    United Kingdom

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    Dundee, DD1 9SY
    United Kingdom

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    Dundee 2650752, DD1 9SY
    United Kingdom

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    Glasgow, G12 0YN
    United Kingdom

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    Glasgow 2648579, G12 0YN
    United Kingdom

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    London, EC1M 6BQ
    United Kingdom

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    London 2643743, NW3 2QG
    United Kingdom

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    Manchester, M8 5RB
    United Kingdom

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    Manchester 2643123, M8 5RB
    United Kingdom

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    Nottingham, NG5 1PB
    United Kingdom

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    Nottingham 2641170, NG5 1PB
    United Kingdom

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    Rotherham, S65 2QL
    United Kingdom

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    Rotherham 2639093, S65 2QL
    United Kingdom

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    Salford, M6 8HD
    United Kingdom

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    Wakefield, WF1 4DG
    United Kingdom

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    Wakefield 2634910, WF1 4DG
    United Kingdom

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    York, YO24 3WX
    United Kingdom

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    York 2633352, YO24 3WX
    United Kingdom

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    Newport Beach, California 92663
    United States

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    Newport Beach 5376890, California 5332921 92663
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    Clearwater, Florida 33765
    United States

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    DeLand, Florida 32720
    United States

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    Lake Wales, Florida 33853
    United States

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    Miami, Florida 33186
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    Orlando, Florida 32825
    United States

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    Tampa, Florida 33606
    United States

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    Winter Park, Florida 32789
    United States

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    Clearwater 4151316, Florida 4155751 33765
    United States

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    DeLand 4152890, Florida 4155751 32720
    United States

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    Miami 4164138, Florida 4155751 33186
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    Orlando 4167147, Florida 4155751 32825
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    Tampa 4174757, Florida 4155751 33606
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    Winter Park 4178560, Florida 4155751 32789
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    Chicago Ridge, Illinois 60415
    United States

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    Chicago Ridge 4887492, Illinois 4896861 60415
    United States

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    Ann Arbor, Michigan 48109
    United States

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    Ann Arbor 4984247, Michigan 5001836 48109
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    Chesterfield, Missouri 63017
    United States

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    Saint Charles, Missouri 63301
    United States

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    Chesterfield 4381072, Missouri 4398678 63017
    United States

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    Saint Charles 4406831, Missouri 4398678 63301
    United States

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    New Windsor, New York 12553
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    New Windsor 5128577, New York 5128638 12553
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    Gastonia, North Carolina 28054
    United States

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    Kernersville, North Carolina 27284
    United States

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    New Bern, North Carolina 28562
    United States

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    Gastonia 4467732, North Carolina 4482348 28054
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    Kernersville 4474221, North Carolina 4482348 27284
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    New Bern 4481682, North Carolina 4482348 28562
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    Columbus, Ohio 43215
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    Columbus 4509177, Ohio 5165418 43215
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    Choctaw, Oklahoma 73020
    United States

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    Choctaw 4533130, Oklahoma 4544379 73020
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    Fort Mill, South Carolina 29707
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    Fort Mill 4578977, South Carolina 4597040 29707
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    Amarillo, Texas 79106
    United States

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  • Research Site

    Amarillo 5516233, Texas 4736286 79106
    United States

    Site Not Available

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