Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Last updated: January 15, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Heartburn (Pediatric)

Heartburn

Esophageal Disorders

Treatment

Placebo

Tezepelumab

Clinical Study ID

NCT05583227
D5244C00001
2022-001294-31
  • Ages 12-80
  • All Genders

Study Summary

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be 12 to 80 years of age inclusive, at the time of signing theinformed consent/assent.

  2. Weight ≥ 40 kg at Visit 1

  3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming adiagnosis of EoE.

  4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck inthe throat) per week in the 4 weeks prior to Visit 1.

  5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and duringthe course of the study (stable diet is defined as no initiation of single ormultiple elimination diets or reintroduction of previously eliminated food groups).

  6. May be on any background PPI and/or STC, during the course of the study, as long asbackground medications have been stable for at least 8 weeks prior to thescreening/run-in period (Visit 1) and there is agreement not to change backgroundmedication or dosage unless medically indicated, during the screening/run-in andtreatment period.

  7. Participants currently on leukotriene inhibitors and/or steroid treatments forasthma or allergies that are inhaled or administered intranasally, must report astable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).

  8. If a medication for EoE (for example PPI and/or STC) is discontinued prior to thescreening/run-in, there should be a washout period of at least 8 weeks prior toVisit 1. Discontinuation of any marketed biologic (monoclonal or polyclonalantibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1,whichever is longer.

  9. Participants should have previously documented standard of care treatment, whichcould include PPI and/or STC and/or diet.

Exclusion

Exclusion Criteria:

  1. Other gastrointestinal disorders such as active Helicobacter pylori infection,history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis,inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis,diverticulitis, irritable bowel syndrome, or other clinically significantgastrointestinal conditions as per Investigator discretion.

  2. Esophageal stricture that prevents the easy passage of a standard endoscope or anycritical esophageal stricture that requires dilation at screening.

  3. Use of a feeding tube, or having a pattern of not eating solid food >3 days of week.Solid food is defined as food that requires chewing before swallowing.

  4. Hypereosinophilic syndrome

  5. EGPA vasculitis

  6. Esophageal dilation performed within 8 weeks prior to screening.

Study Design

Total Participants: 368
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 10, 2022
Estimated Completion Date:
March 23, 2027

Study Description

The study consists of a screening period of 2 to 8 weeks and a 52-week randomized double-blind placebo-controlled treatment period. After completion of the treatment period, participants will be eligible to participate in an optional active treatment extension period (lasting for 24 weeks), followed by a 12-week off-treatment safety follow-up period. Participants who will not participate in the extension period will participate in a 12-week off-treatment safety follow-up period following completion of the 52-week treatment period.

This study will randomize approximately 360 participants. The participants will be randomized at 1:1:1 ratio to the 3 treatment arms.

Connect with a study center

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    Elizabeth Vale, 5112
    Australia

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    Elizabeth Vale 9973185, 5112
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    Kogarah, 2217
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    Kogarah 2161185, 2217
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    Mitcham, 3132
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    South Brisbane, QL 4101
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    South Brisbane 2207259, QL 4101
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    Woolloongabba, 4102
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    Woolloongabba 6943568, 4102
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    Graz, 8036
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    Vienna 2761369, 1090
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    Wels 2761524, 4600
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    Wels-Grieskirchen, 4600
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    Wien, 1090
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    Bruges 2800931, 8310
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    Brugge, 8310
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    Edegem, 2650
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    Edegem 2799007, 2650
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    Gent, 9000
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    Ghent 2797656, 9000
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    Leuven, 3000
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    Leuven 2792482, 3000
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    Botucatu, 18618-687
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    Botucatu 3469136, 18618-687
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    Brasilia, 71681-603
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    Brasília 3469058, 71681-603
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    Caxias do Sul, 95070-560
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    Caxias do Sul 3466537, 95070-560
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    Curitiba, 80250-060
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    Curitiba 3464975, 80250-060
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    Porto Alegre, 90050-170
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    Porto Alegre 3452925, 90035-903
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    Sao Paulo, 05.403-010
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    São José do Rio Preto, 15090-000
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    São José do Rio Preto 3448639, 15090-000
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    São Paulo 3448439, 05.403-010
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    Hamilton, Ontario L8S 1G5
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    London, Ontario N6A 5W9
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    Niagara Falls, Ontario L2H 1H5
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    Ottawa, Ontario K1G 6C6
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    Windsor, Ontario N8X 2G1
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    Hamilton 5969782, Ontario 6093943 L8S 1G5
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    London 6058560, Ontario 6093943 N6A 5W9
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    Beijing, 100050
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    Beijing 1816670, 100020
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    Changsha, 430033
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    Guangzhou, 510515
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    Guangzhou 1809858, 510080
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    Hangzhou, 310052
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    Hangzhou 1808926, 310052
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    Nanjing, 2100008
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    Nanjing 1799962, 2100008
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    Shanghai 1796236, 200000
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    Shenyang, 110004
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    Brno 3078610, 625 00
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    Hradec Kralove, 500 12
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    Hradec Králové 3074967, 500 12
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    Prague 3067696, 190 00
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    Odense, 5000
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    Odense 2615876, 5000
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    Helsinki 658225, 00290
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    Hämeenlinna, 13530
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    Padua 3171728, 35128
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    Pisa, 56124
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    Pisa 3170647, 56124
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    Roma, 00161
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    Roma 8957247, 00161
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    Rozzano 3168837, 20089
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    Verona 3164527, 37134
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    Akita 2113126, 010-8543
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    Akita-shi, 010-8543
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    Fukuoka 1863967, 812-8582
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    Fukuoka-shi, 812-8582
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    Himeji, 670-8560
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    Maebashi-shi, 371-8511
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    Minato-ku, 105-8471
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    Osaka, 545-8586
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    Osaka 1853909, 545-8586
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    Shinjuku-ku, 160-8582
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    Yamagata 2110556, 990-9585
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    Yamagata-shi, 990-9585
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    Amsterdam, 1081 HV
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    Amsterdam 2759794, 1081 HV
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    Nijmegen, 6525 GA
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    Nijmegen 2750053, 6525 GA
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    Rotterdam, 3015 GD
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    Rotterdam 2747891, 3015 GD
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    Christchurch, 8011
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    Christchurch 2192362, 8011
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    Grafton, 1023
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    Hamilton, 3204
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    Hamilton 2190324, 3204
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    Newtown, 6021
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    Newtown 6244789, 6021
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    Otahuhu, 2025
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    Otahuhu 6232009, 2025
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    Wellington, 2820
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    Lørenskog, N-1478
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    Oslo, 0450
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    Oslo 3143244, 0450
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    Tromsø 3133895, N-9038
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    Ålesund, 6026
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    Ålesund 3163392, 6026
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    Kosice, 04013
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    Košice 724443, 04013
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    Martin, 03601
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    Barcelona, 08035
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    Barcelona 3128760, 08036
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    Bilbao (Vizcaya), 48013
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    Madrid, 28031
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    Madrid 3117735, 28007
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    Pamplona, 31008
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    Pamplona 3114472, 31008
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    Sevilla, 41013
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    Seville 2510911, 41009
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    Tomelloso, 13700
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    Tomelloso 2510392, 13700
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    Stockholm, 17164
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    Stockholm 2673730, 171 76
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    Trollhättan, 461 73
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    Trollhättan 2667303, 461 73
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    Uppsala, 751 85
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    Uppsala 2666199, 751 85
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    Brighton, BN2 1ES
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    London, WC1N 3JH
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    Phoenix, Arizona 85016
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    Los Angeles, California 90033
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    Aurora, Colorado 80045
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    Aurora 5412347, Colorado 5417618 80045
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    Inverness, Florida 34452
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    Jacksonville, Florida 32256
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    Saint Augustine, Florida 32086
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    Inverness 4159786, Florida 4155751 34452
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    Jacksonville 4160021, Florida 4155751 32256
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    Saint Augustine 4170894, Florida 4155751 32086
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    Atlanta, Georgia 30322
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    Chicago, Illinois 60611
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    Normal, Illinois 61761
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    Normal 4903780, Illinois 4896861 61761
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    Iowa City, Iowa 52242
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    Iowa City 4862034, Iowa 4862182 52242
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    Topeka, Kansas 66606
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    Topeka 4280539, Kansas 4273857 66606
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    White Marsh, Maryland 21162
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    White Marsh 4373426, Maryland 4361885 21162
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    Boston, Massachusetts 02111
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    Boston 4930956, Massachusetts 6254926 02111
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    Chesterfield, Michigan 48047
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    Chesterfield 4988681, Michigan 5001836 48047
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    Lincoln, Nebraska 68503
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    Lincoln 5072006, Nebraska 5073708 68503
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    Ocean City, New Jersey 07712
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    Teaneck, New Jersey 07666
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    Ocean City 4503351, New Jersey 5101760 07712
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    Brooklyn, New York 11235
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    Brooklyn 5110302, New York 5128638 11235
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    Chapel Hill, North Carolina 27599
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    Winston-Salem, North Carolina 27157
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    Chapel Hill 4460162, North Carolina 4482348 27599
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    Cincinnati, Ohio 45229
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    Cincinnati 4508722, Ohio 5165418 45229
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    Philadelphia, Pennsylvania 19104
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    Smithfield, Pennsylvania 15478
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    Philadelphia 4560349, Pennsylvania 6254927 19104
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    Smithfield 4561301, Pennsylvania 6254927 15478
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    Greenville, South Carolina 29615
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    Nashville, Tennessee 37232
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    Nashville 4644585, Tennessee 4662168 37232
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    Houston, Texas 77030
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    Houston 4699066, Texas 4736286 77030
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    Salt Lake City, Utah 84107
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    Salt Lake City 5780993, Utah 5549030 84132
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    Charlottesville, Virginia 22908
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