A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
NCT ID: NCT03622593
Last Updated: 2025-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
951 participants
INTERVENTIONAL
2018-10-09
2023-05-31
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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A: Faricimab 6 mg Q8W
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
Sham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
Sham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
Aflibercept
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Sham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
Interventions
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Aflibercept
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Faricimab
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
Sham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
* Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
* Decreased visual acuity attributable primarily to DME
* Ability and willingness to undertake all scheduled visits and assessments
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion Criteria
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
* Currently pregnant or breastfeeding, or intend to become pregnant during the study
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
* Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
* Prior administration of IVT faricimab in either eye
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States
California Retina Consultants
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
California Retina Consultants
Santa Barbara, California, United States
California Retina Consultants
Santa Maria, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
University of Colorado
Aurora, Colorado, United States
Retina Consultants of Southern
Colorado Springs, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States
Fort Lauderdale Eye Institute
Plantation, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Prairie Retina Center
Springfield, Illinois, United States
Retina Specialists
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Associated Retinal Consultants
Grand Rapids, Michigan, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
Retina Consultants of Nevada
Las Vegas, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, United States
New York University
New York, New York, United States
Ophthalmic Cons of Long Island
Oceanside, New York, United States
Retina Assoc of Western NY
Rochester, New York, United States
University of Rochester Flaum Eye Institute
Rochester, New York, United States
The Retina Consultants
Slingerlands, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Retina Consultants Of Carolina
Greenville, South Carolina, United States
Charleston Neuroscience Inst
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Pacific Northwest Retina
Silverdale, Washington, United States
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
Fundacion Zambrano
CABA, , Argentina
Oftalmos
Capital Federal, , Argentina
Oftar
Mendoza, , Argentina
Centro Oftalmólogos Especialistas
Rosario, , Argentina
Grupo Laser Vision
Rosario, , Argentina
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Sydney West Retina
Westmead, New South Wales, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
Hospital de Olhos de Aparecida - HOA
Aparecida de Goiânia, Goiás, Brazil
Centro Brasileiro de Cirurgia
Goiânia, Goiás, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Botelho Hospital da Visao
Blumenau, Santa Catarina, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X
São Paulo, São Paulo, Brazil
CEMAPE - Centro Médico
São Paulo, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, Brazil
Calgary Retina Consultants
Calgary, Alberta, Canada
University of British Columbia - Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, Canada
Ivey Eye Institute
London, Ontario, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
University Health Network Toronto Western Hospital
Toronto, Ontario, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Beijing Friendship Hospital
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Southwest Hospital , Third Military Medical University
Chongqing, , China
Army Medical Center of PLA(Daping Hospital)
Chongqing, , China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, , China
Shanghai Tenth People's Hospital
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Tianjin Eye Hospital
Tianjin, , China
Tianjin Medical University Eye Hospital
Tianjin, , China
Eye Hospital, Wenzhou Medical University
Wenzhou, , China
Wuxi No.2 People's Hospital
Wuxi, , China
FN Hradec Králové, O?ní klinika
Hradec Králové, , Czechia
Faculty Hospital Ostrava
Ostrava, , Czechia
Faculty Hospital Kralovske Vinohrady
Prague, , Czechia
AXON Clinical
Prague, , Czechia
Nemocnice Sokolov
Sokolov, , Czechia
Aalborg Universitetshospital
Aalborg, , Denmark
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
Chi De Creteil
Créteil, , France
Centre Ophtalmologique
Paris, , France
Centres Ophtalmologique St Exupéry
Saint-Cyr-sur-Loire, , France
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Dresden, , Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, , Germany
LMU Klinikum der Universität, Augenklinik
München, , Germany
Klinikum rechts der Isar der TU München
München, , Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, , Germany
The University of Hong Kong
Hong Kong, , Hong Kong
Hong Kong Eye Hospital
Mong Kok, , Hong Kong
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Budapest, , Hungary
Semmelweis Egyetem Szemészeti Vizsgálóhely
Budapest, , Hungary
Bajcsy-Zsilinszky Hospital
Budapest, , Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma
Rome, Lazio, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello
Pisa, Tuscany, Italy
Ospedale Classificato Equiparato Sacro Cuore Don Calabria
Negrar, Veneto, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, Italy
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, , Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, , Poland
Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
Rzeszów, , Poland
Caminomed
Tarnowskie Góry, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, , Portugal
Espaco Medico Coimbra
Coimbra, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov
Cheboksary, Mariy-El Republic, Russia
Clinics of Eye Diseases, LLC
Kazan', Tatarstan Republic, Russia
?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
Irkutsk, , Russia
?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
Novosibirsk, , Russia
National University Hospital
Singapore, , Singapore
Singapore Eye Research Institute
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center.
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, Spain
Oftalvist Valencia
Burjassot, Valencia, Spain
Hospital dos de maig
Barcelona, , Spain
Clinica Baviera
Madrid, , Spain
Fisabio-Ofalmologia Medica
Valencia, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Vista Klinik Ophthalmologische Klinik
Binningen, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, , Thailand
Ankara University Medical Faculty; Department of Ophthalmology
Ankara, , Turkey (Türkiye)
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Ankara, , Turkey (Türkiye)
Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology
Istanbul, , Turkey (Türkiye)
Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
Kocaeli, , Turkey (Türkiye)
Barnet Hospital
Barnet, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital
Bristol, , United Kingdom
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
Bristol, , United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, , United Kingdom
Frimley Park Hospital
Frimley, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, , United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Manchester Royal Eye Hospital
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Hillingdon Hospital
Uxbridge, , United Kingdom
Countries
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References
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Wong TY, Haskova Z, Asik K, Baumal CR, Csaky KG, Eter N, Ives JA, Jaffe GJ, Korobelnik JF, Lin H, Murata T, Ruamviboonsuk P, Schlottmann PG, Seres AI, Silverman D, Sun X, Tang Y, Wells JA, Yoon YH, Wykoff CC; YOSEMITE and RHINE Investigators. Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials. Ophthalmology. 2024 Jun;131(6):708-723. doi: 10.1016/j.ophtha.2023.12.026. Epub 2023 Dec 28.
Jaffe GJ, Deak G, Gibson K, Khurana RN, Nudleman E, Ogura Y, Schmidt-Erfurth U, Wang T, Westenskow PD, Wong D, Yiu G, Willis JR. IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS. Retina. 2025 Nov 1;45(11):2003-2011. doi: 10.1097/IAE.0000000000004572.
Chakravarthy U, Chaudhary V, Sadda SR, Tan CS, Vujosevic S, Fauser S, Gibson K, Glittenberg C, Holekamp N, Lanza B, Maunz A, Willis JR, Singh RP. Effect of Faricimab versus Aflibercept on Hyperreflective Foci in Patients with Diabetic Macular Edema from the YOSEMITE/RHINE Trials. Ophthalmol Sci. 2025 Apr 19;5(5):100798. doi: 10.1016/j.xops.2025.100798. eCollection 2025 Sep-Oct.
Goldberg RA, Mar FA, Csaky K, Amador M, Khanani AM, Gibson K, Kolomeyer AM, Sim DA, Murata T, Wang T, Udaondo P, Souverain A, Shildkrot YE, Vujosevic S, Nudleman E, Sivaprasad S. Resolution of Angiographic Macular Leakage with Faricimab versus Aflibercept in Patients with Diabetic Macular Edema in YOSEMITE/RHINE. Ophthalmol Retina. 2025 Jun;9(6):515-526. doi: 10.1016/j.oret.2024.11.015. Epub 2024 Nov 22.
Stockwell AD, Chang MC, Mahajan A, Forrest W, Anegondi N, Pendergrass RK, Selvaraj S, Reeder J, Wei E, Iglesias VA, Creps NM, Macri L, Neeranjan AN, van der Brug MP, Scales SJ, McCarthy MI, Yaspan BL. Multi-ancestry GWAS analysis identifies two novel loci associated with diabetic eye disease and highlights APOL1 as a high risk locus in patients with diabetic macular edema. PLoS Genet. 2023 Aug 16;19(8):e1010609. doi: 10.1371/journal.pgen.1010609. eCollection 2023 Aug.
Shimura M, Kitano S, Ogata N, Mitamura Y, Oh H, Ochi H, Ohsawa S, Hirakata A; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. Jpn J Ophthalmol. 2023 May;67(3):264-279. doi: 10.1007/s10384-023-00979-8. Epub 2023 Mar 10.
Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.
Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-005105-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GR40398
Identifier Type: -
Identifier Source: org_study_id
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