Ensayo en fase III, doble ciego, aleatorizado y controlado con placebo del tratamiento adyuvante con ganaxolona (GNX) en niños y adultos con epilepsia relacionada con el complejo de esclerosis tuberosa (CET) (TrustTSC).

Datos básicos

Código:
1042-TSC-3001
Protocolo:
1042-TSC-3001
EUDRACT:
2021-003441-38
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2022
Año de finalización:
2023
ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar la seguridad y la eficacia de GNX en comparación con el placebo como tratamiento complementario para las crisis epilépticas asociadas al CET en niños y adultos según la evaluación del cambio desde el inicioa en la frecuencia de crisis epilépticas motoras y focales graves (criterio de valoración principal de crisisb) durante la fase doble ciego. Objetivos Secundarios: - Determinar el porcentaje de cambio desde el inicio en la frecuencia de las crisis del criterio de valoración principal de 28 días durante el periodo de mantenimiento. - Evaluar el cambio en la frecuencia de las crisis focales desde el inicioa durante la fase doble ciego. - Evaluar los cambios en el estado de ánimo, el comportamiento y la calidad de vida mediante lo siguiente: o ADAMS o Peds-QL-FIM o SF-36 o ELDQOL - Evaluar el resultado clínico general utilizando las puntuaciones de CGI-I por parte del médico y el progenitor/cuidador. - Evaluar los cambios en la intensidad y la duración de las crisis utilizando la CGI-CSID.

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

MARINUS PHARMACEUTICALS EMERALD LIMITED

Resultados del Ensayo Clínico


[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence

Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda

Editorial Material. 10.1016/j.farma.2024.08.009. 2024

  • Open Access.

[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Andrés JLP, Solsona MDE

Article. 10.1016/j.farma.2023.10.004. 2024


[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024


[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025


[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

  • Open Access.

12-Month Effectiveness and Tolerability of Brivaracetam in the Real-World: The International EXPERIENCE Pooled Analysis

Villanueva, Vicente; (...); Steinhoff, Bernhard J.

Meeting Abstract. 10.1212/WNL.0000000000201896. 2023


A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022


A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA).

Hahn, Cecil D.; (...); Dlugos, Dennis

Article. 10.1111/epi.17367. 2022


Anti-GAD65-related epilepsy and its clinical spectrum

Marin Gracia, M.; (...); Villanueva, V.

Meeting Abstract. 2024


Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).

Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ

Letter. 10.1111/jdv.19432. 2023


BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice

Villanueva, V.; (...); Sansa, G.

Meeting Abstract. 2024


BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice.

Villanueva V; (...); Serratosa JM

Article. 10.1002/epi4.13078. 2024


Brivaracetam effectiveness and tolerability in older and younger adults with epilepsy: EXPERIENCE, a pooled analysis of international data from retrospective studies.

Faught, Edward; (...); Villanueva, Vicente

Article. 10.1016/j.yebeh.2024.109922. 2024


Candidate Selection for Implantation: Noninvasive Predictors of Seizure Onset Zone Focality and Surgical Outcome in People with Drug-Resistant Epilepsy Evaluated by Intracranial Video-EEG Monitoring-A Retrospective Cohort Study

Jannone-Pedro, Nicolas; (...); Villanueva, Vicente

Article. 10.1155/2023/3455061. 2023


Cannabidiol therapy for refractory epilepsy in paediatric real world setting: What's the benefit?

Smeyers, P.; (...); Hernandez, S.

Meeting Abstract. 2024


Cenobamate in real-life setting: Final outcomes of an expanded access program

Villanueva-Haba, V.; (...); Massot-Tarrus, A.

Meeting Abstract. 2023


CLINICAL AND ECONOMIC CONSEQUENCES OF EPILEPSY TREATMENT ACROSS INCREMENTAL TREATMENT LINES IN SPAIN: A REAL LIFE DATABASE ANALYSIS

Toledano, R.; (...); Hernandez, I

Meeting Abstract. 2023


Clinical and economic implications of epilepsy management across treatment lines in Spain: a real-life database analysis.

Toledano R; (...); Pérez-Domper P

Article. 10.1007/s00415-023-11958-x. 2023


Clinical characteristics of patients achieving seizure freedom in a phase 2 trial evaluating adjunctive cenobamate

Brandt, C.; (...); Steinhoff, B.

Meeting Abstract. 2022


Cognitive adverse events of adjunctive eslicarbazepine acetate in children with refractory focal seizures

Smeyers, P.; (...); Gama, H.

Meeting Abstract. 2022


Cognitive and Behavioral Effects of Adjunctive Brivaracetam in Children and Adolescents with Focal Seizures: Final Data From an Open-label Follow-up Trial

Elshoff, Jan-Peer; (...); Smeyers, Patricia

Meeting Abstract. 10.1212/WNL.0000000000201877. 2023


Cognitive phenotypes in patients with drug-resistant temporal lobe epilepsy: Relationships with cortisol and affectivity.

Cano-Lopez, Irene; (...); Gonzalez-Bono, Esperanza

Article. 10.1080/13854046.2024.2375605. 2024


Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023


Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023


COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN

Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.

Meeting Abstract. 2024


Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.

Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL

Editorial Material. 10.1016/j.farma.2024.08.001. 2024


Design of two parallel randomized, double-blind, placebo-controlled phase 3 studies to evaluate the safety and efficacy of XEN1101 as adjunctive therapy in the treatment of focal onset epilepsy

Perucca, E.; (...); Beatch, G. N.

Meeting Abstract. 2023


Determination of the economically justifiable price of cenobamate in the treatment of focal-onset seizures in adult patients with drug-resistant epilepsy in Spain.

Angel Calleja, Miguel; (...); Gil, Alicia

Article. 10.1080/14737167.2022.2107507. 2022


Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024


Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024


Development and validation of the Epilepsy Perceived Stress Inventory for Adults (EPSI-A): A pilot study

Catalan-Aguilar, Judit; (...); Gonzalez-Bono, Esperanza

Article. 10.1016/j.yebeh.2024.110142. 2024


Effect of concomitant medications on adverse event frequency, severity, and resolution in a cenobamate open-label trial

Steinhoff, B.; (...); Villanueva, V.

Meeting Abstract. 2024


Effectiveness and Tolerability of 12-Month Brivaracetam in the Real World: EXPERIENCE, an International Pooled Analysis of Individual Patient Records.

Villanueva V; (...); Steinhoff BJ

Article. 10.1007/s40263-023-01033-4. 2023


Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis.

Szaflarski, Jerzy P; (...); Villanueva, Vicente

Article. 10.1007/s00415-024-12253-z. 2024


Effectiveness, safety and tolerability of perampanel by age group when used to treat people with focal and generalized epilepsy in clinical practice: The PERMIT Extension study.

Wheless J; (...); Villanueva V

Article. 10.1016/j.yebeh.2023.109369. 2023


Efficacy and safety of stiripentol in the prevention and cessation of status epilepticus: A systematic review.

Specchio N; (...); Trinka E

Article. 10.1002/epi4.13036. 2024


Efficacy of add-on Cenobamate treatment in refractory epilepsy due to Rasmussen's encephalitis.

Schulze-Bonhage A; (...); Villanueva V

Article. 10.1002/epi4.13060. 2024


Efficacy of stiripentol in the management of status epilepticus: A systematic review

Auvin, S.; (...); Trinka, E.

Meeting Abstract. 2024


Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024


How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022


Impact of antiseizure medication with a very long half-life on long term video-EEG monitoring in focal epilepsy.

Hampel, Kevin G.; (...); Villanueva, Vicente

Article. 10.1016/j.seizure.2023.12.010. 2023


Impact of Polytherapy on Memory Functioning in Patients With Drug-Resistant Epilepsy: The Role of Attention and Executive Functions.

Lozano-Garcia, Alejandro; (...); Gonzalez-Bono, Esperanza

Article. 10.1093/arclin/acad086. 2023


Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024


Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024


Long-Term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures.

Klein, Pavel; (...); Villanueva, Vicente

Article. 10.1212/WNL.0000000000200792. 2022


Long-term, quality of life in epilepsy inventory-31 (QOLIE-31) improvements in adults with focal onset seizures treated with XEN1101 in an ongoing, open-

Brandt, C.; (...); Beatch, G. N.

Meeting Abstract. 2024


Management of patients with Dravet syndrome in real-world clinical practice across five countries in Europe: Impact of treatment-related burden on health outcomes

Ross, E.; (...); Andrews, J. S.

Meeting Abstract. 2024


Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022


National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022


New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024


Number needed to treat and associated cost analysis of cenobamate versus third-generation anti-seizure medications for the treatment of focal-onset seizures in patients with drug-resistant epilepsy in Spain.

Villanueva, Vicente; (...); Gil, Alicia

Article. 10.1016/j.yebeh.2022.109054. 2023


Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022


ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023


Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023


OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024


Patient profile, management, and quality of life associated with Dravet syndrome: a cross-sectional, multicentre study of 80 patients in Spain.

Gil-Nagel, Antonio, Sanchez-Carpintero, Rocio, Villanueva, Vicente

Article. 10.1038/s41598-023-30273-z. 2023


Perampanel as Early Add on Therapy for Epilepsy Patients with Focal -Onset an Generalized-Onset Seizures Treated in Clinical Practice(p1-1.Virtua)

Santamarina, Estevo; (...); Villanueva, Vicente

Meeting Abstract. 2022


Perampanel as Early Add on Therapy for Epilepsy Patients with Focal -Onset and Generalized-Onset Seizures Treated in Clinical Practice(p1-1.Virtual)

Santamarina, Estevo; (...); Villanueva, Vicente

Meeting Abstract. 2022


Perampanel for the treatment of Asian people with epilepsy: Real-world evidence from the PERMIT extension study.

Wu, Tony; (...); Villanueva, Vicente

Article. 10.1016/j.jns.2024.123173. 2024


Perampanel for the treatment of epilepsy with genetic aetiology: Real-world evidence from the PERMIT Extension study.

Delanty N; (...); Villanueva V

Article. 10.1016/j.eplepsyres.2024.107339. 2024


Perampanel for the treatment of patients with myoclonic seizures in clinical practice: Evidence from the PERMIT study

D'Souza, Wendyl; (...); Villanueva, Vicente

Article. 10.1016/j.seizure.2022.06.008. 2022


Perampanel for the Treatment of People with Idiopathic Generalized Epilepsy in Clinical Practice.

Trinka E; (...); Villanueva V

Article. 10.1111/epi.17631. 2023


Perampanel for treatment of epilepsy with tumour, vascular or traumatic brain injury aetiology: Evidence from the PERMIT extension study

Strzelczyk, A.; (...); Villanueva, V.

Meeting Abstract. 2024


Perampanel for treatment of focal and generalized epilepsy in everyday clinical practice: Evidence from permit extension

Trinka, Eugen; (...); Villanueva, Vicente

Meeting Abstract. 10.1016/j.jns.2023.121561. 2023


Perampanel for Treatment of People with a Range of Epilepsy Aetiologies in Clinical Practice: Evidence from the PERMIT Extension Study.

Strzelczyk, Adam; (...); Villanueva, Vicente

Article. 10.1007/s40120-024-00618-5. 2024


Perampanel Monotherapy for Focal and Generalized Epilepsy in Clinical Practice

Chinvarun, Yotin; (...); Villanueva, Vicente

Article. 10.1155/2023/2852853. 2023


Perampanel outcomes at different stages of treatment in people with focal and generalized epilepsy treated in clinical practice: Evidence from the PERMIT study.

Liguori, Claudio; (...); Villanueva, Vicente

Article. 10.3389/fneur.2023.1120150. 2023


Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

  • Open Access.

Presurgical Use of Cenobamate for Adult and Pediatric Patients Referred for Epilepsy Surgery: Expert Panel Recommendations.

Laxer KD; (...); Villanueva V

Article. 10.1007/s40120-024-00651-4. 2024


Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study.

Astner-Rohracher, Alexandra; (...); Frauscher, Birgit

Article. 10.1136/bmjno-2024-000765. 2024


Proposed Recommendations for the Management of Depression in Adults with Epilepsy: An Expert Consensus.

Villanueva, Vicente; (...); Bobes, Julio

Article. 10.1007/s40120-023-00437-0. 2023


Prospective study of cenobamate on cognition, affectivity and quality of life in focal epilepsy.

Catalan-Aguilar, Judit; (...); Villanueva, Vicente

Article. 10.1002/epi4.12857. 2023


Real-life evidence about the use of intravenous brivaracetam in urgent seizures: The BRIV-IV study.

Villanueva V; (...); Escalza I

Article. 10.1016/j.yebeh.2023.109384. 2023


Real-world clinical burden of non-seizure symptoms among patients with dravet syndrome or Lennox- Gastaut syndrome in Europe: Results from a global multinational survey

Berthoz, F. Truong; (...); Andrews, J. S.

Meeting Abstract. 2024


Real-World Experience of Perampanel Monotherapy in Epilepsy Patients with Focal-Onset and Generalized-Onset Seizures

Alsaadi, Taoufik; (...); Villanueva, Vicente

Meeting Abstract. 2022


Real-world safety and effectiveness of cenobamate in patients with focal onset seizures: outcomes from an Expanded Access Program.

Villanueva, Vicente; (...); Rodriguez-Uranga, Juan J.

Article. 10.1002/epi4.12757. 2023


Refractory status epilepticus due to vitamin B6 deficit in a Parkinson's disease patient in treatment with levodopa/carbidopa intestinal gel

Baviera-Munoz, R.; (...); Martinez-Torres, I.

Letter. 10.1016/j.nrl.2021.10.002. 2022


Refractory status epilepticus due to vitamin B6 deficit in a Parkinson's disease patient in treatment with levodopa/carbidopa intestinal gel.

Baviera-Muñoz R; (...); Martinez-Torres I

Article. 10.1016/j.nrleng.2021.10.002. 2022


Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.

Nabbout, Rima; (...); Cross, J. Helen

Article. 10.1016/j.seizure.2023.05.003. 2023


Severe Communication Delays Are Independent of Seizure Burden and Persist Despite Contemporary Treatments in SCN1A+ Dravet Syndrome: Insights from the ENVISION Natural History Study.

Perry, M. Scott; (...); Rico, Salvador

Article. 10.1111/epi.17850. 2023


Spanish consensus on the management of concomitant antiseizure medications when using cenobamate in adults with drug-resistant focal seizures.

Carreño M; (...); Villanueva V

Article. 10.1002/epi4.12936. 2024


Stereoencephalography-guided thermocoagulation: Experience in our centre

De Castro Garcia, A. Celdran; (...); Villanueva, V.

Meeting Abstract. 2024


Stress phenotypes in epilepsy: impact on cognitive functioning and quality of life.

Catalán-Aguilar J; (...); Cano-López I

Article. 10.3389/fpsyg.2023.1100101. 2023


Sustained =90% response and seizure freedom in patients with focal-onset seizures treated with cenobamate

Alvarez-Baron, E., Thangavelu, K., Villanueva, V.

Meeting Abstract. 2023


The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity

Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar

Article. 10.1007/s00431-022-04628-z. 2022


The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

Gil-Nagel A; (...); Gil A

Article. 10.1016/j.yebeh.2022.108711. 2022


The Charlotte Project: Recommendations for patient-reported outcomes and clinical parameters in Dravet syndrome through a qualitative and Delphi consensus study.

Aledo-Serrano Á; (...); Sánchez-Carpintero R

Article. 10.3389/fneur.2022.975034. 2022


The relationship between memory and quality of life is mediated by trait anxiety in patients with temporal lobe epilepsy.

Cano-Lopez, Irene; (...); Gonzalez-Bono, Esperanza

Article. 10.1007/s11136-022-03306-9. 2022


The significance of very long half-life in the context of antiseizure medication withdrawal during long-term video-EEG monitoring.

Hampel, Kevin Gil; (...); Villanueva, Vicente

Letter. 10.1016/j.seizure.2024.01.006. 2024


The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

  • Open Access.

Therapeutic strategies during cenobamate treatment initiation: Delphi panel recommendations

Steinhoff, Bernhard J.; (...); Villanueva, Vicente

Review. 10.1177/17562864241256733. 2024


Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024


Treatment patterns and disease burden among patients with Lennox- Gastaut syndrome in Europe: A real-world survey

Benitez, A.; (...); Andrews, J. S.

Meeting Abstract. 2024


Triplication of the PCDH19 Gene as a Novel Disease Mechanism Leading to Epileptic Encephalopathy Resembling Loss-of-Function Pathogenic Variants.

Gabaldón-Albero A; (...); Martínez F

Article. 10.3390/genes15101312. 2024

  • Open Access.

Use of Stiripentol in Patients with Dravet Syndrome: Common Practice Among Experts in Spain.

Garcia-Penas, Juan Jose; (...); Sanchez-Carpintero, Rocio

Article. 10.1007/s40120-024-00677-8. 2024


VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023


What do 90-99% responder rates mean in patients treated with cenobamate: results from an open label extension study

Serratosa, J.; (...); Villanueva, V.

Meeting Abstract. 2023


What do 90-99% responder rates mean in patients treated with cenobamate: results from the open label extension (OLE) of study C017?

Serratosa, J. M.; (...); Villanueva, V.

Meeting Abstract. 2023


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