SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
NCT ID: NCT05629962
Last Updated: 2025-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2285 participants
INTERVENTIONAL
2022-11-25
2024-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bemnifosbuvir (BEM)
Bemnifosbuvir (BEM)
BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
Placebo
Placebo
Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days
Interventions
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Bemnifosbuvir (BEM)
BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
Placebo
Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening
* Subject must be high risk, defined below:
1. Age ≥70 years OR
2. Age ≥55 years with one of the following: i) obesity (body mass index \[BMI\] ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR
3. Age 50 to 54 years with two of the following: i) obesity (BMI ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR
4. Age ≥18 years with one of the following: i) Down syndrome, sickle cell disease, dementia, Parkinson's disease, or care home residents ii) One of the following immunocompromising conditions or immunosuppressive treatments: receiving chemotherapy for cancer, hematologic malignancy, being within 2 years of a hematopoietic stem cell transplant, receipt of a solid organ transplant and on immunosuppressive therapy, human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count \<350 cells per cubic millimeter, moderate/severe primary immunodeficiency, taking immunosuppressive medications
* Use of adequate contraception for females of childbearing potential
Exclusion Criteria
* Admitted to a hospital within 90 days prior to randomization due to COVID-19
* Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study
* Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection
* Requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (≥ 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted.
* Other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis C virus (HCV) or HIV providing other eligibility criteria are met.
* Receiving dialysis or have known severe renal impairment
* History of severe hepatic impairment (Child-Pugh Class C)
* Known allergy or hypersensitivity to components of study drug
18 Years
ALL
No
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Kingman, Arizona, United States
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Prescott, Arizona, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Fullerton, California, United States
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Inglewood, California, United States
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La Palma, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Coral Gables, Florida, United States
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Cutler Bay, Florida, United States
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Doral, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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North Miami Beach, Florida, United States
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North Miami Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Pompano Beach, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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The Villages, Florida, United States
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West Miami, Florida, United States
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West Palm Beach, Florida, United States
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Eatonton, Georgia, United States
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Orland Park, Illinois, United States
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La Vista, Nebraska, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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High Point, North Carolina, United States
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Chickasha, Oklahoma, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Rock Hill, South Carolina, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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DeSoto, Texas, United States
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Forney, Texas, United States
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Fort Worth, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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Lewisville, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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Splendora, Texas, United States
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Stafford, Texas, United States
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Sugar Land, Texas, United States
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Bahía Blanca, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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San Nicolás de los Arroyos, Buenos Aires, Argentina
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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Córdoba, , Argentina
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Santiago del Estero, , Argentina
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Maceió, Alagoas, Brazil
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Fortaleza, Ceará, Brazil
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Fortaleza, Ceará, Brazil
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Cachoeiro de Itapemirim, Espírito Santo, Brazil
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Serra, Espírito Santo, Brazil
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Vitória, Espírito Santo, Brazil
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Salvador, Estado de Bahia, Brazil
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Salvador, Estado de Bahia, Brazil
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Brasília, Federal District, Brazil
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Cuiabá, Mato Grosso, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Campina Grande do Sul, Paraná, Brazil
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Rio de Janeiro, Rio Do Janeiro, Brazil
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Natal, Rio Grande do Norte, Brazil
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Natal, Rio Grande do Norte, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Velho, Rondônia, Brazil
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Blumenau, Santa Catarina, Brazil
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Florianópolis, Santa Catarina, Brazil
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Itajaí, Santa Catarina, Brazil
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Itajaí, Santa Catarina, Brazil
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Joinville, Santa Catarina, Brazil
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Barretos, São Paulo, Brazil
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Bento Gonçalves, São Paulo, Brazil
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Botucatu, São Paulo, Brazil
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Campinas, São Paulo, Brazil
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Ijuí, São Paulo, Brazil
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Jaú, São Paulo, Brazil
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Osasco, São Paulo, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Santa Catarina, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Valinhos, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Edmonton, Alberta, Canada
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Chicoutimi, Quebec, Canada
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Munich, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hyderabad, Andhra Pradesh, India
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Nellore, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Nellore, Andhra Prasesh, India
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Ahmedabad, Gujarat, India
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Gotri, Gujarat, India
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Surat, Gujarat, India
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Surat, Gujarat, India
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Faridabad, Haryana, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bengaluru, Karnataka, India
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Dombivali, Maharashtra, India
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Nashik, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Jaipur, Rajasthan, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Fukuoka, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Fukuoka, Fukuoka City, Japan
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Sapporo, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Tsuchiura, Ibaraki, Japan
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Kanazawa, Ishikawa-ken, Japan
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Fujisawa, Kanagawa, Japan
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Kamakura, Kanagawa, Japan
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Izumisano, Osaka, Japan
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Toda, Saitama, Japan
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Uozu, Toyama, Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Okayama, , Japan
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Daugavpils, , Latvia
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Riga, , Latvia
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Saltillo, Coahuila, Mexico
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Torreón, Coahuila, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Querétaro City, Querétaro, Mexico
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Cancún, Quintana Roo, Mexico
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San Luis Potosí City, San Luis Potos, Mexico
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Yucatán, Yucatán, Mexico
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Chihuahua City, , Mexico
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Oaxaca City, , Mexico
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Puebla City, , Mexico
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Veracruz, , Mexico
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Veracruz, , Mexico
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The Hague, , Netherlands
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The Hague, , Netherlands
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Utrecht, , Netherlands
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Zwijndrecht, , Netherlands
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Zwijndrecht, , Netherlands
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Islamabad, , Pakistan
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Karachi, , Pakistan
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Karachi, , Pakistan
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Lahore, , Pakistan
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Rawalpindi, , Pakistan
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Baguio City, Cordillera, Philippines
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Tacloban City, Leyte, Philippines
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Ermita, Manila, Philippines
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San Fernando City, Pampanga, Philippines
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Iloilo City, , Philippines
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Mandaluyong, , Philippines
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Baloteşti, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Craiova, , Romania
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Oradea, , Romania
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Sibiu, , Romania
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Suceava, , Romania
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Timișoara, , Romania
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East London, Eastern Cape, South Africa
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Randburg, Gauteng, South Africa
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Thabazimbi, Limpopo, South Africa
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Kimberley, Northern Cape, South Africa
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Cape Town, Western Cape, South Africa
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Plettenberg Bay, Western Cape, South Africa
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Badalona, Barcelona, Spain
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Centelles, Barcelona, Spain
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Marbella, Malaga, Spain
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Málaga, Malaga, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Solna, , Sweden
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Umeå, , Sweden
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La Marsa, , Tunisia
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Monastir, , Tunisia
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Montfleury, , Tunisia
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Sfax, , Tunisia
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Sousse, , Tunisia
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Sousse, , Tunisia
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Tunis, , Tunisia
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Tunis, , Tunisia
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Denizli, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Yenimahalle, , Turkey (Türkiye)
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Exeter, Devon, United Kingdom
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Plymouth, Devon, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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Castleford, West Yourkshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AT-03A-017
Identifier Type: -
Identifier Source: org_study_id
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