A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
NCT ID: NCT05305547
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2093 participants
INTERVENTIONAL
2022-08-03
2024-05-24
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
DOUBLE
Study Groups
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S-217622
S-217622 will be administered orally for 5 days.
S-217622
Administered as a round tablet.
Placebo
Placebo matching to S-217622 will be administered orally for 5 days.
Placebo
Administered as a round tablet.
Interventions
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S-217622
Administered as a round tablet.
Placebo
Administered as a round tablet.
Eligibility Criteria
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Inclusion Criteria
* Participants are expected to begin study intervention ≤3 days from self-reported date of onset of any of the COVID-19-related symptoms from the following list:
* Cough
* Shortness of breath or difficulty breathing
* Feeling feverish
* Chills
* Fatigue
* Body pain or muscle pain or aches
* Diarrhea
* Nausea
* Vomiting
* Headache
* Sore throat
* Nasal obstruction or congestion
* Nasal discharge
* Loss of taste
* Loss of smell
* One or more of the following signs/symptoms present within 24 hours prior to randomization:
* Cough
* Shortness of breath or difficulty breathing
* Feeling feverish
* Chills
* Fatigue
* Body pain or muscle pain or aches
* Diarrhea
* Nausea
* Vomiting
* Headache
* Sore throat
* Nasal obstruction or congestion
* Nasal discharge
* Participants at higher risk of progression to severe COVID-19 are defined as follows:
* Age ≥65 years
* Age ≥18 with 1 of the following:
* Obesity (body mass index \[BMI\] ≥30 kilograms per square meter \[kg/m\^2\]). Note: BMI is rounded to the nearest whole number, for example 29.5 kg/m\^2 is rounded to 30 kg/m\^2.
* Diabetes mellitus
* Hypertension requiring daily prescribed therapy
* Cardiovascular disease (requiring daily prescribed therapy or congenital heart disease)
* Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) requiring daily prescribed therapy
* Chronic kidney disease, defined as known current kidney impairment with a creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \<60 milliliters (mL)/minute (min)/1.73 square meter (m\^2) within the past 12 months prior to randomization, as long as the participant does not have known CrCl \<30 mL/min by Cockcroft-Gault or require dialysis
* Down syndrome
* Sickle cell disease
* One of the following immunocompromising conditions or immunosuppressive treatments:
* Receiving chemotherapy or other therapies for cancer
* Hematologic malignancy (active or in remission)
* History of a hematopoietic stem cell or a solid organ transplant
* Human immunodeficiency virus infection: not on antiretroviral therapy or with cluster of differentiation 4+ cell count \<200 cells per cubic millimeter
* Combined primary immunodeficiency disorder
* Taking immunosuppressive medications (for example, drugs to suppress rejection of transplanted organs or to treat rheumatologic and gastrointestinal conditions, such as anti-tumor necrosis factor agents, mycophenolate, and rituximab).
Note: Current use of some corticosteroids is exclusionary, due to concern for possible drug-drug interaction (DDI) with S-217622.
Exclusion Criteria
* For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP, or nasal swab, or saliva) collected ˃72 hours (3 days) prior to randomization. Participants with reinfection, defined as prior SARS-CoV-2 infection that began \>90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization.
* Current need for hospitalization or immediate medical attention in the opinion of the investigator
* Current use of any medications prohibited with the study intervention. Individuals who have used Paxlovid or any other oral, inhaled, or injectable medication intended to treat the current SARS-CoV-2 infection before randomization are excluded. After randomization, locally available SARS-CoV-2 treatment (including but not limited to molnupiravir, mAbs, outpatient IV remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for DDIs.
Note: Paxlovid use for a prior episode of COVID-19 is permitted.
* Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any time prior to randomization is exclusionary. Note: This does not include drugs approved for other uses and taken for those indications or COVID-19 vaccines. Note: Use of locally authorized or approved therapies to prevent COVID-19, such as mAbs given solely to prevent COVID-19, are not exclusionary.
* Any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization
* Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622
* Known (within 12 months prior to randomization) renal impairment defined as CrCl \<30 mL/min by Cockcroft-Gault or requiring dialysis
* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy)
* Participants who have used any of the following drugs within 14 days prior to randomization:
* Strong cytochrome P453A inducer
* Products containing St. John's Wort
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Shionogi
INDUSTRY
Responsible Party
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Locations
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Lakeview Clinical Research
Guntersville, Alabama, United States
Voyage Medical Services
Tempe, Arizona, United States
Novak Clinical Research
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
Carbon Health
Culver City, California, United States
NICR
Garden Grove, California, United States
Ark Clinical Research (PARENT)
Long Beach, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
University of California San Francisco (PARENT)
San Francisco, California, United States
Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
Thousand Oaks, California, United States
Lundquist Institute for BMI, UCLA Medical Center
Torrance, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
University of Florida Clinical & Translational Science Institute
Gainesville, Florida, United States
Universal Medical and Research Center
Miami, Florida, United States
CCR Medical Center, Suite 201
Miami, Florida, United States
Miami Clinical Research
Miami, Florida, United States
Vista Health Research, LLC
Miami, Florida, United States
Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
Miami Beach, Florida, United States
Quality Research of South Florida
Miami Lakes, Florida, United States
Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
Ormond Beach, Florida, United States
Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
Pompano Beach, Florida, United States
Invictus Clinical Research Group, LLC
Pompano Beach, Florida, United States
Santos Research Center, CORP
Tampa, Florida, United States
Masters of Clinical Research
Augusta, Georgia, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
Research Network America
Berwyn, Illinois, United States
Rush University Infectious Diseases
Chicago, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Infusion Associates
Grand Rapids, Michigan, United States
Revival Research Institute LLC
Troy, Michigan, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
Columbia University Irving Medical Center Division of Infectious Diseases
New York, New York, United States
NY Blood Center Project ACHIEVE
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Lapis Clinical Research - North State
Denver, North Carolina, United States
Burke Primary Care
Morgantown, North Carolina, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
Ohio State University College of Medicine
Columbus, Ohio, United States
Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
UPMC Eye Center - Eye and Ear Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt Health-One Hundred Oaks
Nashville, Tennessee, United States
Central Texas Medical Research
Austin, Texas, United States
Care United Research, 375 North FM 548, suite 100
Forney, Texas, United States
Valley Institute of Research
Fort Worth, Texas, United States
Trio Clinical Trials, LLC.
Houston, Texas, United States
Accurate Clinical Management, LLC
Houston, Texas, United States
Sun Research Institute, LLC
San Antonio, Texas, United States
Progressive Clinical Research
Bountiful, Utah, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio De La Trinidad, Mitre Bartolome Mitre
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Privado de Medicina Familiar, Mindout Research
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro De Investigaciones
Mar del Plata, Buenos Aires, Argentina
DIM Clínica Privada, Belgrano 136 - 5to piso
Ramos Mejía, Buenos Aires, Argentina
Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes
Ramos Mejía, Buenos Aires, Argentina
Clínicas Zárate, F. Andrade 332
Zárate, Buenos Aires, Argentina
Sanatorio Privado ,Duarte Quiros
Quiros, Córdoba Province, Argentina
Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
Rosario, Sante Fe, Argentina
Clinica Mayo UMCB
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica Olivos
Buenos Aires, , Argentina
Sanatorio Allende, Av.
Córdoba, , Argentina
CER San Juan,
San Juan, , Argentina
Mendoza 2612, Rosario
Santa Fe, , Argentina
SENAI CIMATEC Clinical Trial Research Center
Salvador, Estado de Bahia, Brazil
AMB3 Servicos Medicos Ltda Rua Campinas
Cuiabá, Mato Grosso, Brazil
Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161
Belo Horizonte, Minas Gerais, Brazil
Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
Curitiba, Paraná, Brazil
Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
Natal, Rio Grande do Norte, Brazil
Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
Porto Alegre, Rio Grande do Sul, Brazil
IPARGS, Rua Antonio Joaquim Mesquita
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
Baretos, São Paulo, Brazil
Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
Botucatu, São Paulo, Brazil
Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
Bragança Paulista, São Paulo, Brazil
Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
Campinas, São Paulo, Brazil
Cecip Jau
Jaú, São Paulo, Brazil
Pesquisare Saude
Santo André, São Paulo, Brazil
CEMEC
São Bernardo do Campo, São Paulo, Brazil
Esperanca Clinica De Pesquisas
São Paulo, São Paulo, Brazil
Instituto de Molestast Cardiovasculares
Tatuí, São Paulo, Brazil
Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
Campinas, , Brazil
IBPClin, Rua da Gloria
Rio de Janeiro, , Brazil
INI/Fiocruz
Rio de Janeiro, , Brazil
Lóbus Cntr. de Pesquisa Cl.
Volta Redonda, , Brazil
Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
Medellín, Antioquia, Colombia
Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
Barranquilla, Atlántico, Colombia
Corazon IPS S.A.S, Carrera 49 No 74 - 158
Barranquilla, Atlántico, Colombia
IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
Barranquilla, Atlántico, Colombia
Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
Bogotá, Bogota D.C., Colombia
Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,
Chuchurubi Monteria, Departamento de Córdoba, Colombia
TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino
Santa Marta, Magdalena Department, Colombia
Fundación Cardiomet Cequin,, Street 18 North # 14-25,
Armenia, Quindío Department, Colombia
BlueCare Salud SAS
Bogotá, , Colombia
Navrongo Health Research Cntr
Upper East, Navrongo, Ghana
Kintampo Health Research Cntr
Kintampo, , Ghana
Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University
Kumasi, , Ghana
St. Theresa's Hospital
Hyderabad, Andhra Pradesh, India
DEC-Health Care Hospital
Nellore, Andhra Pradesh, India
Vijaya Super Speciality Hospital
Nellore, Andhra Pradesh, India
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Sangini Hospital 1st Flr & 7th flr
Ahmedabad, Gujarat, India
Aman Hospital and Research Center
Vadodara, Gujarat, India
Rhythm Heart Institute - A Unit Of SLPL
Vadodara, Gujarat, India
ESIC Medical College & Hospital
Faridabad, Haryana, India
Sarvodaya Hospital and Research Centre
Faridabad, Haryana, India
BGS Global institute of Medical Sciences
Bangalore, Karnataka, India
KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
Belagavi, Karnataka, India
Sri Lakshmi Super Speciality Hospital
Bengaluru, Karnataka, India
Shettys Hospital
Bengaluru, Karnataka, India
Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
Bengaluru, Karnataka, India
Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
Mangalore, Karnataka, India
BAJ RR Hosp and Res Cntr
Dombivali, Maharashtra, India
Chopda Medicare & Research Centre Pvt. Ltd
Nashik, Maharashtra, India
Lifepoint Multispecialty Hosp.
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Aakash Healthcare Private Limited
Dwārka, New Delhi, India
JNUIMSRC
Jaipur, Rajasthan, India
Tagore Hospital & Research Institute
Jaipur, Rajasthan, India
Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
Chennai, Tamil Nadu, India
Department of Medicine
Kanpur, Uttar Pradesh, India
HB Specialty Hosp. & Res Inst.
Rudrapur, Uttarakhand, India
Calcutta School of Tropical Medicine
Kolkata, West Bengal, India
Kohokai Takagi Hospital
Okawa-shi, Fukuuoka-Ken, Japan
Tsuchiura Beryl Clinic
Tsuchiura-shi, Ibaraki, Japan
University of Tsukuba Hospital
Tsuchiura-shi, Ibaraki, Japan
Tashiro Endocrinology Clinic
Tsukuba, Ibaraki, Japan
Kodaira Hospital
Toda-shi, Saitama, Japan
Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
Eldoret, , Kenya
KEMRI CGHR HIVR Site
Kisumu, , Kenya
Johns Hopkins Research Project, Queen Elizabeth Central Hospital
Chipatala Avenue, Blantyre, Malawi
UNC Project, Private Bag A-104
Lilongwe, , Malawi
Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805
Mangochi, , Malawi
CAIMED Investigación en Salud, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
Cuauhtémoc, Cdmx, C.P, Mexico
Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
Veracruz, CP, Mexico
Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
Cuernavaca, Morelos, Mexico
Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
Oaxaca City, Oaxaca, Mexico
Centro Inv. y Avances Med Especializados, (CIAME) Av. Kabah, Lote 38, 39 y 41., Manzana 4, supermanzana 44. Col., Alborada, Benito Juárez
Cancún, Quintana Roo, Mexico
FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
Ricardo Flores Magón, Veracruz, Mexico
Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
Aguascalientes, , Mexico
Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso
Aguascalientes, , Mexico
Indus Hospital and Health Network
Korangi, Karachi, Pakistan
Rehman Medical Institute Clinical Trial Unit
Hayatabad, Peshawar, Pakistan
Central Park Teaching Hospital
Lahore, Punjab Province, Pakistan
National Hospital & Medical Center
Lahore, Punjab Province, Pakistan
Akram Medical Complex
Lahore, Punjab Province, Pakistan
The Aga Khan University
Karachi, Sindh, Pakistan
Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
Islamabad, , Pakistan
Dow Univ of Health Sciences Ojha Campus
Karachi, , Pakistan
Sindh Infectious Disease Hospital and research Centre
Karachi, , Pakistan
Maroof International Hospital
Peshawar, , Pakistan
Centro de Investigación
San Isidro, Lima region, Peru
Asoc. Civil Selva Amazonica
Iquitos, Loreto, Peru
Centro de Inv. Tecnológicas Biomédicas y Medioambientales
Lima, , Peru
Asoc. Civil Impacta Salud y Educación - Sede San Miguel
Lima, , Peru
Patricia Ortiz Bazan
Lima Cercado, , Peru
Mary Mediatrix Medical Cntr
Lipa, Batangas, Philippines
Mary Johnston Hospital, 1221 Juan Nolasco Street
Tondo, Manila, Philippines
Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
Lloilo, Molo, Philippines
The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone
Mabalacat, Pampanga, Philippines
Ilocos Training and Regional Medical Center
La Union, San Fernando, Philippines
Green City Medical Center
Pampanga, San Fernando, Philippines
Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
Mandaluyong, , Philippines
Lung Center of the Philippines
Quezon City, , Philippines
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, , Poland
Medicome sp. z o.o.
Oświęcim, , Poland
Centrum Medyczne "Medyk"
Rzeszów, , Poland
Clinmedica Research sp. z o.o.
Skierniewice, , Poland
Centrum Badań Klinicznych
Wroclaw, , Poland
JOSHA Research
Bloemfontein, Free State, South Africa
Newton Clinical Research Centre
Johanesburg, Gauteng, South Africa
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Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
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Pathum Wan, Bangkok, Thailand
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Mueang Khon Kaen District, Changwat Khon Kaen, Thailand
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Kampala, , Uganda
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SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
Lira, , Uganda
IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd
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Countries
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References
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Luetkemeyer AF, Chew KW, Lacey S, Hughes MD, Harrison LJ, Daar ES, Eron J, Fletcher CV, Greninger AL, Hessinger D, Li JZ, Mailhot D, Wohl D, Chayakulkeeree M, Mendoza JLA, Elistratova P, Makinde O, Morgan G, Portsmouth S, Uehara T, Smith D, Currier JS. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial. Clin Infect Dis. 2025 Jul 18;80(6):1235-1244. doi: 10.1093/cid/ciaf029.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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ACTIV-2d/A5407
Identifier Type: -
Identifier Source: org_study_id
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