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NCT02257736Active, not recruitingPhase 3

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
982 (actual)
First submitted
2 Oct 2014
Start date
26 Nov 2014
Primary completion date
19 Mar 2018
Lead sponsor
Aragon Pharmaceuticals, Inc.
NCT number
NCT02257736
EU CT number
2023-508606-26-00
EudraCT number
2014-001718-25

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 982
  • From 26 Nov 2014 to the primary completion date, 19 Mar 2018
  • 160 sites in 16 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

  • Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example \[eg\], saw palmetto, pomegranate) or c) Any investigational agent

Other

  • Small cell or neuroendocrine carcinoma of the prostate
  • Known brain metastases
  • At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)

Who the study is looking for

  • Adenocarcinoma of the prostate
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (\>=) 2 centimeter (cm) in the longest diameter
  • Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) \>= 2 nanogram per milliliters (ng/mL)
  • Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
  • Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2
  • Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.

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

Full criteria on ClinicalTrials.gov

Sites (160)

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

SiteCityCountrySite status
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Ciudad Automoma Buenos AiresArgentinaUnknown status
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Ciudad de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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La RiojaArgentinaUnknown status
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MendozaArgentinaUnknown status
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RosarioArgentinaUnknown status
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AdelaideAustraliaUnknown status
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AshfordAustraliaUnknown status
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CamperdownAustraliaUnknown status
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HerstonAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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MalvernAustraliaUnknown status
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MelbourneAustraliaUnknown status
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SouthportAustraliaUnknown status
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WahroongaAustraliaUnknown status
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West HeidelbergAustraliaUnknown status
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WoolloongabbaAustraliaUnknown status
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AntwerpBelgiumUnknown status
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BrusselsBelgiumUnknown status
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GhentBelgiumUnknown status
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GosseliesBelgiumUnknown status
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LeuvenBelgiumUnknown status
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LiègeBelgiumUnknown status
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NamurBelgiumUnknown status
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OttigniesBelgiumUnknown status
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RoeselareBelgiumUnknown status
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Sint-NiklaasBelgiumUnknown status
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BarretosBrazilUnknown status
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IjuíBrazilUnknown status
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NatalBrazilUnknown status
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Porto AlegreBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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Abbotsford British ColumbiaCanadaUnknown status
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BarrieCanadaUnknown status
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HalifaxCanadaUnknown status
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KelownaCanadaUnknown status
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LondonCanadaUnknown status
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MontrealCanadaUnknown status
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OakvilleCanadaUnknown status
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QuébecCanadaUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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VancouverCanadaUnknown status
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WestonCanadaUnknown status
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
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AngersFranceUnknown status
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CaenFranceUnknown status
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DijonFranceUnknown status
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Le MansFranceUnknown status
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LyonFranceUnknown status
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MontpellierFranceUnknown status
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ParisFranceUnknown status
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Saint-HerblainFranceUnknown status
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ToulouseFranceUnknown status
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AyrUnited KingdomUnknown status
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BelfastUnited KingdomUnknown status
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BirminghamUnited KingdomUnknown status
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EdinburghUnited KingdomUnknown status
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GlasgowUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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Metropolitan Borough of WirralUnited KingdomUnknown status
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PlymouthUnited KingdomUnknown status
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PrestonUnited KingdomUnknown status
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StevenageUnited KingdomUnknown status
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SuttonUnited KingdomUnknown status
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Westcliff-on-SeaUnited KingdomUnknown status
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FukuokaJapanUnknown status
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KanazawaJapanUnknown status
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KashiwaJapanUnknown status
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Kita-GunJapanUnknown status
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KumamotoJapanUnknown status
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KurumeJapanUnknown status
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MatsuyamaJapanUnknown status
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MiyazakiJapanUnknown status
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NagasakiJapanUnknown status
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OsakaJapanUnknown status
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Ōsaka-sayamaJapanUnknown status
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SakuraJapanUnknown status
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SapporoJapanUnknown status
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UbeJapanUnknown status
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YokohamaJapanUnknown status
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Goyang-siSouth KoreaUnknown status
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SeongnamSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Chihuahua CityMexicoUnknown status
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CuernavacaMexicoUnknown status
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CuliacánMexicoUnknown status
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MéxicoMexicoUnknown status
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Oaxaca CityMexicoUnknown status
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ZapopanMexicoUnknown status
Academisch Medisch Centrum
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AmsterdamNetherlandsCompleted
Amsterdam UMC
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AmsterdamNetherlandsCompleted
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsCompleted
Zuyderland Medisch Centrum Stichting
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GeleenNetherlandsCompleted
Stichting Martini Ziekenhuis
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GroningenNetherlandsCompleted
Tergooiziekenhuizen
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HilversumNetherlandsCompleted
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Haga Hospital
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's-GravenhageNetherlandsCompleted
St Antonius Ziekenhuis
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UtrechtNetherlandsCompleted
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KurskRussiaUnknown status
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MoscowRussiaUnknown status
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OmskRussiaUnknown status
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PyatigorskRussiaUnknown status
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Rostov-on-DonRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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UfaRussiaUnknown status
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AlbanyUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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AuburnUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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CharlestonUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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DenverUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Jensen BeachUnited StatesUnknown status
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Johnson CityUnited StatesUnknown status
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LakelandUnited StatesUnknown status
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La MesaUnited StatesUnknown status
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LancasterUnited StatesUnknown status
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Las VegasUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MadisonUnited StatesUnknown status
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MarreroUnited StatesUnknown status
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MelroseUnited StatesUnknown status
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ModestoUnited StatesUnknown status
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Myrtle BeachUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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New OrleansUnited StatesUnknown status
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New Port RicheyUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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NilesUnited StatesUnknown status
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NorfolkUnited StatesUnknown status
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OcalaUnited StatesUnknown status
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OmahaUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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PoughkeepsieUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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Santa BarbaraUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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ShreveportUnited StatesUnknown status
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SpokaneUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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SyracuseUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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TualatinUnited StatesUnknown status
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WenatcheeUnited StatesUnknown status
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BloemfonteinSouth AfricaUnknown status
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Cape TownSouth AfricaUnknown status
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JohannesburgSouth AfricaUnknown status
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PretoriaSouth AfricaUnknown status

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