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NCT07228832RecruitingPhase 3

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
900 (estimated)
First submitted
10 Nov 2025
Start date
18 Nov 2025
Primary completion date
31 May 2028
Lead sponsor
Summit Therapeutics
NCT number
NCT07228832

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 900
  • From 18 Nov 2025 to the primary completion date, 31 May 2028
  • 207 sites in 15 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

  • Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
  • Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)

Other illness

  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
  • Resectable disease

Other

  • Known BRAF V600E mutant status
  • Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
  • Ascites requiring paracentesis within last 30 days

Who the study is looking for

  • ECOG performance status score of 0 or 1
  • Expected life expectancy ≥ 6 months
  • Patients with histologically or cytologically confirmed metastatic CRC
  • No prior systemic therapy for metastatic CRC
  • At least 1 measurable noncerebral lesion

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (207)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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BrusselsBelgiumRecruiting
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GhentBelgiumRecruiting
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Haine-Saint-PaulBelgiumRecruiting
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KortrijkBelgiumRecruiting
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BramptonCanadaRecruiting
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MontrealCanadaRecruiting
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ReginaCanadaRecruiting
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TorontoCanadaRecruiting
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VancouverCanadaRecruiting
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BeijingChinaRecruiting
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Ch’ang-ch’unChinaRecruiting
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ChangshaChinaRecruiting
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ChengduChinaRecruiting
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ChifengChinaRecruiting
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FoshanChinaRecruiting
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FuzhouChinaRecruiting
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GuangzhouChinaRecruiting
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HaikouChinaRecruiting
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HangzhouChinaRecruiting
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HarbinChinaRecruiting
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JinanChinaRecruiting
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KunmingChinaRecruiting
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LuzhouChinaRecruiting
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NanchangChinaRecruiting
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NanjingChinaRecruiting
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NingboChinaRecruiting
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ShanghaiChinaRecruiting
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ShenyangChinaRecruiting
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ShenzhenChinaRecruiting
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ShijiazhuangChinaRecruiting
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TianjinChinaRecruiting
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WenzhouChinaRecruiting
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WuhanChinaRecruiting
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YueyangChinaRecruiting
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ZhengzhouChinaRecruiting
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ZhuhaiChinaRecruiting
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BrnoCzechiaRecruiting
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Hradec KrálovéCzechiaRecruiting
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OlomoucCzechiaRecruiting
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PragueCzechiaRecruiting
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BerlinGermanyRecruiting
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BonnGermanyRecruiting
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HamburgGermanyRecruiting
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A CoruñaSpainRecruiting
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BarcelonaSpainRecruiting
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CórdobaSpainRecruiting
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GranadaSpainRecruiting
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MadridSpainRecruiting
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MálagaSpainRecruiting
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Palma de MallorcaSpainRecruiting
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SantanderSpainRecruiting
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SevilleSpainRecruiting
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ValenciaSpainRecruiting
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BordeauxFranceRecruiting
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LilleFranceRecruiting
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LyonFranceRecruiting
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MarseilleFranceRecruiting
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MontpellierFranceRecruiting
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NancyFranceRecruiting
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NantesFranceRecruiting
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NiceFranceRecruiting
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ParisFranceRecruiting
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Pierre-BéniteFranceRecruiting
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PoitiersFranceRecruiting
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ReimsFranceRecruiting
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StrasbourgFranceRecruiting
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VillejuifFranceRecruiting
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AberdeenUnited KingdomRecruiting
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CanterburyUnited KingdomRecruiting
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EdinburghUnited KingdomRecruiting
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LiverpoolUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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ManchesterUnited KingdomRecruiting
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NorthwoodUnited KingdomRecruiting
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BudapestHungaryRecruiting
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DebrecenHungaryRecruiting
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KecskemétHungaryRecruiting
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AvianoItalyRecruiting
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BresciaItalyRecruiting
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FlorenceItalyRecruiting
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GenovaItalyRecruiting
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MeldolaItalyRecruiting
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MilanItalyRecruiting
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PisaItalyRecruiting
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RomaItalyRecruiting
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VeronaItalyRecruiting
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AichiJapanRecruiting
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ChibaJapanRecruiting
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EhimeJapanRecruiting
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FukuokaJapanRecruiting
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GifuJapanRecruiting
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HiroshimaJapanRecruiting
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HokkaidoJapanRecruiting
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KawasakiJapanRecruiting
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OsakaJapanRecruiting
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SaitamaJapanRecruiting
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SendaiJapanRecruiting
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ShizuokaJapanRecruiting
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TokyoJapanRecruiting
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ToyamaJapanRecruiting
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YokohamaJapanRecruiting
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Aguas CalientesMexicoRecruiting
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Mexico CityMexicoRecruiting
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MonterreyMexicoRecruiting
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Oaxaca CityMexicoRecruiting
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GdanskPolandRecruiting
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OlsztynPolandRecruiting
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OtwockPolandRecruiting
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RzeszówPolandRecruiting
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WarsawPolandRecruiting
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Rio PiedrasPuerto RicoRecruiting
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AkronUnited StatesRecruiting
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AtlantaUnited StatesRecruiting
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AuroraUnited StatesRecruiting
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BaltimoreUnited StatesRecruiting
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Beverly HillsUnited StatesRecruiting
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BillingsUnited StatesRecruiting
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BostonUnited StatesRecruiting
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BurlingtonUnited StatesRecruiting
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CamdenUnited StatesRecruiting
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CantonUnited StatesRecruiting
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CerritosUnited StatesRecruiting
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CharlestonUnited StatesRecruiting
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CharlottesvilleUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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CincinnatiUnited StatesRecruiting
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ClevelandUnited StatesRecruiting
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CoronaUnited StatesRecruiting
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DallasUnited StatesRecruiting
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DanversUnited StatesRecruiting
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DenverUnited StatesRecruiting
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DetroitUnited StatesRecruiting
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DuarteUnited StatesRecruiting
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EdgewoodUnited StatesRecruiting
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ElmhurstUnited StatesRecruiting
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FairfaxUnited StatesRecruiting
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Fort WayneUnited StatesRecruiting
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Fort WorthUnited StatesRecruiting
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Fountain ValleyUnited StatesRecruiting
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GermantownUnited StatesRecruiting
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GoodyearUnited StatesRecruiting
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GreenvilleUnited StatesRecruiting
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HartfordUnited StatesRecruiting
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HermitageUnited StatesRecruiting
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HialeahUnited StatesRecruiting
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Highlands RanchUnited StatesRecruiting
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HoustonUnited StatesRecruiting
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Huntington BeachUnited StatesRecruiting
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IndianapolisUnited StatesRecruiting
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IrvineUnited StatesRecruiting
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LebanonUnited StatesRecruiting
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LincolnUnited StatesRecruiting
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Lone TreeUnited StatesRecruiting
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Los AngelesUnited StatesRecruiting
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MadisonUnited StatesRecruiting
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Mayfield HeightsUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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Miami BeachUnited StatesRecruiting
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MineolaUnited StatesRecruiting
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MinneapolisUnited StatesRecruiting
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MobileUnited StatesRecruiting
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MurrietaUnited StatesRecruiting
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NewarkUnited StatesRecruiting
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New BrunswickUnited StatesRecruiting
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New HavenUnited StatesRecruiting
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NewnanUnited StatesRecruiting
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New OrleansUnited StatesRecruiting
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NewtonUnited StatesRecruiting
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New YorkUnited StatesRecruiting
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NorwichUnited StatesRecruiting
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OaklandUnited StatesRecruiting
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OcalaUnited StatesRecruiting
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O'FallonUnited StatesRecruiting
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Oklahoma CityUnited StatesRecruiting
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OrangeUnited StatesRecruiting
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OrlandoUnited StatesRecruiting
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PasadenaUnited StatesRecruiting
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PhiladelphiaUnited StatesRecruiting
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PinehurstUnited StatesRecruiting
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PittsburghUnited StatesRecruiting
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PlantationUnited StatesRecruiting
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Port Saint LucieUnited StatesRecruiting
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ProvidenceUnited StatesRecruiting
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RochesterUnited StatesRecruiting
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RosevilleUnited StatesRecruiting
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Saint Louis ParkUnited StatesRecruiting
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Salt Lake CityUnited StatesRecruiting
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San FranciscoUnited StatesRecruiting
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Santa ClaraUnited StatesRecruiting
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SellersvilleUnited StatesRecruiting
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SpartanburgUnited StatesRecruiting
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SpokaneUnited StatesRecruiting
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SpringfieldUnited StatesRecruiting
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StanfordUnited StatesRecruiting
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St. PetersburgUnited StatesRecruiting
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SyracuseUnited StatesRecruiting
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TacomaUnited StatesRecruiting
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TamaracUnited StatesRecruiting
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The BronxUnited StatesRecruiting
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TorranceUnited StatesRecruiting
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TuscaloosaUnited StatesRecruiting
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TylerUnited StatesRecruiting
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UplandUnited StatesRecruiting
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VallejoUnited StatesRecruiting
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West HollywoodUnited StatesRecruiting
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WestwoodUnited StatesRecruiting
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White PlainsUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.