| OPPOSITION | - Anonymous, "Australian Public Assessment Report for nusinersen (as heptadecasodium) - Proprietary Product Name: Spinraza", Australian Government, Department of Health - Therapeutic Goods Administration, (20180801), Australian Government, Department of Health - Therapeutic Goods Administration, XP093208578 | - |
| OPPOSITION | - Anonymous, "Australian Public Assessment Report for nusinersen (as heptadecasodium) - Proprietary Product Name: Spinraza", Australian Government, Department of Health - Therapeutic Goods Administration, (20180801), pages 1 - 79, XP093208578 | - |
| OPPOSITION | - Anonymous, "Australian Public Assessment Report for nusinersen (as heptadecasodium)", TGA Health Registration, (20180801), pages 1 - 79, XP093209987 | - |
| OPPOSITION | - Anonymous, "Biogen Announces First Patient Treated With Higher Dose of SPINRAZA® (nusinersen) in Phase 2/3 DEVOTE Study", Biogen, (20200402), pages 1 - 2, Biogen , URL: https://investors.biogen.com/node/21926/pdf, (20240930), XP093209963 | - |
| OPPOSITION | - Anonymous, "Clinical data from Parts 8 and C of the DEVOTE Study, presented at the 29th Annual Congress of the World Muscle Society (WMS)", 29th Annual Congress of the World Muscle Society (WMS), (20241008), XP093264348 | - |
| OPPOSITION | - Anonymous, "Clinical Pharmacology and Biopharmaceutics Review", Centrer for drug evaluation and research, (20160101), pages 1 - 49, XP093210026 | - |
| OPPOSITION | - Anonymous, "Clinical Pharmacology and Biopharmaceutics Review of nusinersen", FDA; APPLICATION NUMBER: 2095310rig1s000, (20160101), XP093208573 | - |
| OPPOSITION | - Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION : SPINRAZA (nusinersen) injection, for intrathecal use", HIGHLIGHTS OF PRESCRIBING INFORMATION, FDA, (20161201), pages 1 - 13, HIGHLIGHTS OF PRESCRIBING INFORMATION , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209531lbl.pdf, XP093208978 | - |
| OPPOSITION | - Anonymous, "ICH Topic E 4 - Dose Response Information to Support Drug Registration", European Medicines Agency; CPMP/ICH/378/95, (19941101), European Medicines Agency; CPMP/ICH/378/95, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-4-dose-response-information-support-drug-registration-step-5_en.pdf, (20240411), XP093150470 | - |
| OPPOSITION | - Anonymous, "New Higher Dose Nusinersen Efficacy and Safety Data Presented at World Muscle Society Congress, Highlight Potential to Maximize Benefit of Nusinersen in SMA", Biogen, (20241008), Biogen, URL: https://investors.biogen.com/node/28421/pdf, XP093264345 | - |
| OPPOSITION | - Anonymous, "Office Director Memo for the approval of nusinersen ", FDA; CENTER FOR DRUG EVALUATION AND RESEARCH - APPLICATION NUMBER: 209531Orig1s000, (20161223), FDA; CENTER FOR DRUG EVALUATION AND RESEARCH - APPLICATION NUMBER: 209531Orig1s000 , URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209531Orig1s000ODMemo.pdf, XP093208582 | - |
| OPPOSITION | - Anonymous, "Spinraza (EMA/289068/2017)", European Medicines agency science medicines health, (20170421), pages 1 - 117, XP093209971 | - |
| OPPOSITION | - Anonymous, "Spinraza (EMEA/H/C/004312/0000)", European medicines agency-science medicines health, (20170421), pages 1 - 117, XP093210023 | - |
| OPPOSITION | - Anonymous, "Spinraza - International non-proprietary name: nusinersen - Assessment report", European Medicines Agency; Procedure No. EMEA/H/C/004312/0000; EMA/289068/2017; Committee for Medicinal Products for Human Use (CHMP), (20170421), XP093208571 | - |
| OPPOSITION | - Australian Public Assessment Report for nusinersen (as heptadecasodium), August 2018 | - |
| OPPOSITION | - Biogen Netherlands B.V., "Spinraza 12 mg solution for injection SUMMARY OF PRODUCT CHARACTERISTICS", SUMMARY OF PRODUCT CHARACTERISTICS, European Medicines Agency, (20170530), pages 1 - 31, SUMMARY OF PRODUCT CHARACTERISTICS, URL: https://www.ema.europa.eu/en/documents/product-information/spinraza-epar-product-information_en.pdf, XP093209916 | - |
| OPPOSITION | - Björn Bornkamp, "11 Dose-Finding Studies in Phase II: Introduction and Overview", Björn Bornkamp, John O'Quigley, Alexia lasonos, Björn Bornkamp, Handbooks of Modern Statistical Methods - Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials, Chapman & Hall/CRC, (2017), pages 189 - 204 | - |
| OPPOSITION | - Chyung S. Cook, Aziz Karim, "Dosage Regimens and Dose-Response", Encyclopedia of Pharmaceutical Technology, Informa Healthcare USA, Inc, (20070101), vol. 1, pages 1012 - 1022, ISBN 0-8493-9396-5, XP009557309 | - |
| OPPOSITION | - D44a - CV PROF. BASIL T. DARRAS M.D. | - |
| OPPOSITION | - D44 - Declaration of Prof. Basil T. Darras M.D., Associate Neurologist-in-Chief at the Department of Neurology, Boston Children's Hospital (BCH) and Professor of Neurology at Harvard Medical SchooI | - |
| OPPOSITION | - Fda, "Guideline for Industry Dose-Response Information to Support Drug Registration", FDA ICH-E4, (19941101), FDA ICH-E4, URL: https://www.fda.gov/media/71279/download, (20200514), XP055695441 | - |
| OPPOSITION | - Patricia Sanwald Ducray , Nicolas Frances , Kevin Smart, Dan Norris , Holly Kordasiewicz , Andreas Guenther , Edward Wild , Scott Schobe, "Translational pharmacokinetic/pharmacodynamic (PK/PD) modelling strategy to support RG6042 dose selection in Huntington’s disease (HD)", AAN 71st Annual Meeting, (20190501), pages 1 - 18, XP093210041 | - |
| OPPOSITION | - R Schmidt, "Dose-Finding Studies in Clinical Drug Development", European Journal of Clinical Pharmacology, (19880101), vol. 34, pages 15 - 19, XP055350888 | - |
| OPPOSITION | - Sanwald Ducray Patricia, Nicolas Frances, Kevin Smart, Dan Norris, Holly Kordasiewicz, Andreas Guenther, Edward Wild, Scott Schobel, "Translational pharmacokinetic/pharmacodynamic (PK/PD) modelling strategy to support RG6042 dose selection in Huntington’s disease (HD)", AAN 71st Annual Meeting, S16.005, (20190501), AAN 71st Annual Meeting, S16.005, URL: https://medically.roche.com/content/dam/pdmahub/non-restricted/neurology/aan-2019/AAN_2019_PKPD_RG6042_Platform_Ducray.pdf, XP093208579 | - |
| OPPOSITION | - Burgart Alyssa, Magnus David, Tabor Holly, Paquette Erin, Frader Joel, Glover Jaqueline, Jackson Brian, Harrison Charlotte, Urion David, Graham Robert, Brandsema John, Feudtner Chris, "Ethical Challenges Confronted When Providing Nusinersen Treatment for Spinal Muscular Atrophy", JAMA pediatrics, American Medical Association, USA, USA , (20180101), vol. 172, no. 2, doi:10.1001/jamapediatrics.2017.4409, ISSN 2168-6203, pages 188 - 192, XP009558619 | |
| OPPOSITION | - Lee Shwu‐luan, Brown Paul, Wang Jian, Dorsam Robert T., "Nonclinical Safety Assessments and Clinical Pharmacokinetics for Oligonucleotide Therapeutics: A Regulatory Perspective", Advanced Delivery and Therapeutic Applications of RNAi, Wiley, (20130610), pages 63 - 81, doi:10.1002/9781118610749.ch4, XP093208518 | |
| OPPOSITION | - Finkel Richard S., Ryan Monique M., Pascual Pascual Samuel Ignacio, Day John W., Mercuri Eugenio, De Vivo Darryl C., Foster Richard, Montes Jacqueline, Gurgel‐giannetti Juliana, Maccannell Drew, Berger Zdenek, "Scientific rationale for a higher dose of nusinersen", Annals of Clinical and Translational Neurology, GB , (20220601), vol. 9, no. 6, doi:10.1002/acn3.51562, ISSN 2328-9503, pages 819 - 829, XP093208505 | |
| OPPOSITION | - Finkel Richard S., Ryan Monique M., Pascual Pascual Samuel Ignacio, Day John W., Mercuri Eugenio, De Vivo Darryl C., Foster Richard, Montes Jacqueline, Gurgel‐giannetti Juliana, Maccannell Drew, Berger Zdenek, "Scientific rationale for a higher dose of nusinersen", Annals of Clinical and Translational Neurology, John Wiley & Sons Ltd., GB, GB , (20220601), vol. 9, no. 6, doi:10.1002/acn3.51562, ISSN 2328-9503, pages 819 - 829, XP093208505 | |
| OPPOSITION | - Darras Basil T., Crawford Thomas O., Finkel Richard S., Mercuri Eugenio, De Vivo Darryl C., Oskoui Maryam, Tizzano Eduardo F., Ryan Monique M., Muntoni Francesco, Zhao Guolin, Staropoli John, Mccampbell Alexander, Petrillo Marco, Stebbins Christopher, Fradette Stephanie, Farwell Wildon, Sumner Charlotte J., "Neurofilament as a potential biomarker for spinal muscular atrophy", Annals of Clinical and Translational Neurology, John Wiley & Sons Ltd., GB, GB , (20190501), vol. 6, no. 5, doi:10.1002/acn3.779, ISSN 2328-9503, pages 932 - 944, XP093264360 | |
| OPPOSITION | - Luu Kenneth T., Norris Daniel A., Gunawan Rudy, Henry Scott, Geary Richard, Wang Yanfeng, "Population Pharmacokinetics of Nusinersen in the Cerebral Spinal Fluid and Plasma of Pediatric Patients With Spinal Muscular Atrophy Following Intrathecal Administrations", The Journal of clinical pharmacology, LIPPINCOTT CO, HAGERSTOWN, MD, US, US , (20170801), vol. 57, no. 8, doi:10.1002/jcph.884, ISSN 0091-2700, pages 1031 - 1041, XP093208501 | |
| OPPOSITION | - Luu Kenneth T., Norris Daniel A., Gunawan Rudy, Henry Scott, Geary Richard, Wang Yanfeng, "Population Pharmacokinetics of Nusinersen in the Cerebral Spinal Fluid and Plasma of Pediatric Patients With Spinal Muscular Atrophy Following Intrathecal Administrations", The Journal of clinical pharmacology, US , (20170801), vol. 57, no. 8, doi:10.1002/jcph.884, ISSN 0091-2700, pages 1031 - 1041, XP093208501 | |
| OPPOSITION | - Alan H. Hartford, Kenneth G. Kowalski, "Pharmacometrics", Alan H. Hartford, Kenneth G. Kowalski, Liang Fang, Cheng Su, Statistical Methods in Biomarker and Early Clinical Development, Springer, (20191227), pages 321 - 348, doi:10.1007/978-3-030-31503-0_15, XP009559704 | |
| OPPOSITION | - Douwe D. Breimer, "PK/PD Modelling and Beyond: Impact on Drug Development", Pharmaceutical Research, Kluwer Academic Publishers-Plenum Publishers, NL, NL , (20080923), vol. 25, no. 12, doi:10.1007/s11095-008-9717-x, ISSN 1573-904X, pages 2720 - 2722, XP019647962 | |
| OPPOSITION | - MacCannell Drew; Berger Zdenek; East Lilly; Mercuri Eugenio; Kirschner Janbernd; Muntoni Francesco; Farrar Michelle A.; Peng Joanna; Zhou Jie; Nestorov Ivan; Farwell Wildon; Finkel Richard S., "Population pharmacokinetics-based recommendations for a single delayed or missed dose of nusinersen", Neuromuscular Disorders, Elsevier Ltd, GB, GB , (20210220), vol. 31, no. 4, doi:10.1016/j.nmd.2021.02.014, ISSN 0960-8966, pages 310 - 318, XP086541913 | |
| OPPOSITION | - MacCannell Drew; Berger Zdenek; East Lilly; Mercuri Eugenio; Kirschner Janbernd; Muntoni Francesco; Farrar Michelle A.; Peng Joanna; Zhou Jie; Nestorov Ivan; Farwell Wildon; Finkel Richard S., "Population pharmacokinetics-based recommendations for a single delayed or missed dose of nusinersen", Neuromuscular Disorders, GB , (20210220), vol. 31, no. 4, doi:10.1016/j.nmd.2021.02.014, ISSN 0960-8966, pages 310 - 318, XP086541913 | |
| OPPOSITION | - Finkel Richard S; Chiriboga Claudia A; Vajsar Jiri; Day John W; Montes Jacqueline; De Vivo Darryl C; Yamashita Mason; Rigo Frank; Hung Gene; Schneider Eugene; Norris Daniel A; Xia Shuting; Bennett C Frank; Bishop Kathie M, "Treatment of infantile-onset spinal muscular atrophy with nusinersen: a phase 2, open-label, dose-escalation study", The Lancet, AMSTERDAM, NL , (20161207), vol. 388, no. 10063, doi:10.1016/S0140-6736(16)31408-8, ISSN 0140-6736, pages 3017 - 3026, XP029849269 | |
| OPPOSITION | - Finkel Richard S; Chiriboga Claudia A; Vajsar Jiri; Day John W; Montes Jacqueline; De Vivo Darryl C; Yamashita Mason; Rigo Frank; Hung Gene; Schneider Eugene; Norris Daniel A; Xia Shuting; Bennett C Frank; Bishop Kathie M, "Treatment of infantile-onset spinal muscular atrophy with nusinersen: a phase 2, open-label, dose-escalation study", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20161207), vol. 388, no. 10063, doi:10.1016/S0140-6736(16)31408-8, ISSN 0140-6736, pages 3017 - 3026, XP029849269 | |
| OPPOSITION | - DERENDORF H, MEIBOHM B, "Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives.", Environmental Science and Pollution Research, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (19990201), vol. 16, no. 2, doi:10.1023/A:1011907920641, ISSN 0724-8741, pages 176 - 185, XP002383973 | |
| OPPOSITION | - Hartmut Derendorf , Bernd Meibohm, "Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives.", Environmental Science and Pollution Research, Berlin/Heidelberg, (19990201), vol. 16, no. 2, doi:10.1023/A:1011907920641, ISSN 0724-8741, pages 176 - 185, XP002383973 | |
| OPPOSITION | - Richard S. Finkel, Eugenio Mercuri, Basil T. Darras, Anne M. Connolly, Nancy L. Kuntz, Janbernd Kirschner, Claudia A. Chiriboga, Kayoko Saito, Laurent Servais, Eduardo Tizzano, Haluk Topaloglu, Már Tulinius, Jacqueline Montes, Allan M. Glanzman, Kathie Bishop, Z. John Zhong, Sarah Gheuens, C. Frank Bennett, Eugene Schneider, Wildon Farwell, Darryl C. De Vivo, "Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy", The New England journal of medicine, Massachusetts Medical Society, US, US , (20171102), vol. 377, no. 18, doi:10.1056/NEJMoa1702752, ISSN 0028-4793, pages 1723 - 1732, XP055528567 | |
| OPPOSITION | - Richard S. Finkel, Eugenio Mercuri, Basil T. Darras, Anne M. Connolly, Nancy L. Kuntz, Janbernd Kirschner, Claudia A. Chiriboga, Kayoko Saito, Laurent Servais, Eduardo Tizzano, Haluk Topaloglu, Már Tulinius, Jacqueline Montes, Allan M. Glanzman, Kathie Bishop, Z. John Zhong, Sarah Gheuens, C. Frank Bennett, Eugene Schneider, Wildon Farwell, Darryl C. De Vivo, "Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy", The New England journal of medicine, Massachusetts Medical Society, US, US , (20171102), vol. 377, no. 18, doi:10.1056/NEJMoa1702752, ISSN 0028-4793, pages 1723 - 1732, XP055528610 | |
| OPPOSITION | - Richard S. Finkel, Eugenio Mercuri, Basil T. Darras, Anne M. Connolly, Nancy L. Kuntz, Janbernd Kirschner, Claudia A. Chiriboga, Kayoko Saito, Laurent Servais, Eduardo Tizzano, Haluk Topaloglu, Már Tulinius, Jacqueline Montes, Allan M. Glanzman, Kathie Bishop, Z. John Zhong, Sarah Gheuens, C. Frank Bennett, Eugene Schneider, Wildon Farwell, Darryl C. De Vivo, "Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy", The New England journal of medicine, US , (20171102), vol. 377, no. 18, doi:10.1056/NEJMoa1702752, ISSN 0028-4793, pages 1723 - 1732, XP055528567 | |
| OPPOSITION | - Tabrizi Sarah J., Leavitt Blair R., Landwehrmeyer G. Bernhard, Wild Edward J., Saft Carsten, Barker Roger A., Blair Nick F., Craufurd David, Priller Josef, Rickards Hugh, Rosser Anne, Kordasiewicz Holly B., Czech Christian, Swayze Eric E., Norris Daniel A., Baumann Tiffany, Gerlach Irene, Schobel Scott A., Paz Erika, Smith Anne V., Bennett C. Frank, Lane Roger M., "Targeting Huntingtin Expression in Patients with Huntington’s Disease", The New England journal of medicine, Massachusetts Medical Society, US, US , (20190613), vol. 380, no. 24, doi:10.1056/NEJMoa1900907, ISSN 0028-4793, pages 2307 - 2316, XP093208569 | |
| OPPOSITION | - Tabrizi Sarah J., Leavitt Blair R., Landwehrmeyer G. Bernhard, Wild Edward J., Saft Carsten, Barker Roger A., Blair Nick F., Craufurd David, Priller Josef, Rickards Hugh, Rosser Anne, Kordasiewicz Holly B., Czech Christian, Swayze Eric E., Norris Daniel A., Baumann Tiffany, Gerlach Irene, Schobel Scott A., Paz Erika, Smith Anne V., Bennett C. Frank, Lane Roger M., "Targeting Huntingtin Expression in Patients with Huntington’s Disease", The New England journal of medicine, US , (20190613), vol. 380, no. 24, doi:10.1056/NEJMoa1900907, ISSN 0028-4793, pages 2307 - 2316, XP093208569 | |
| OPPOSITION | - Chiriboga Claudia A, "Nusinersen for the treatment of spinal muscular atrophy", Expert Review of Neurotherapeutics, (20171003), vol. 17, no. 10, doi:10.1080/14737175.2017.1364159, ISSN 1473-7175, pages 955 - 962, XP093209959 | |
| OPPOSITION | - Chiriboga Claudia A., "Nusinersen for the treatment of spinal muscular atrophy", Expert Review of Neurotherapeutics, Taylor & Francis, (20171003), vol. 17, no. 10, doi:10.1080/14737175.2017.1364159, ISSN 1473-7175, pages 955 - 962, XP093209959 | |
| OPPOSITION | - Teresa Gidaro; Laurent Servais, "Nusinersen treatment of spinal muscular atrophy: current knowledge and existing gaps", Developmental Medicine & Child Neurology, GB , (20180917), vol. 61, no. 1, doi:10.1111/dmcn.14027, ISSN 0012-1622, pages 19 - 24, XP071199370 | |
| OPPOSITION | - Claborn Melanie K., Stevens Debra L., Walker Cheri K., Gildon Brooke L., "Nusinersen: A Treatment for Spinal Muscular Atrophy", Annals of Pharacotherapy, US , (20190101), vol. 53, no. 1, doi:10.1177/1060028018789956, ISSN 1060-0280, pages 61 - 69, XP093209944 | |
| OPPOSITION | - Wurster Claudia D., Ludolph Albert C., "Nusinersen for spinal muscular atrophy", Therapeutic Advances in Neurological Disorders, (20180101), vol. 11, doi:10.1177/1756285618754459, ISSN 1756-2864, pages 1 - 3, XP093208516 | |
| OPPOSITION | - Wurster Claudia D., Ludolph Albert C., "Nusinersen for spinal muscular atrophy", THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS MAY 2010, (20180101), vol. 11, doi:10.1177/1756285618754459, ISSN 1756-2864, page 175628561875445, XP093208516 | |
| OPPOSITION | - Bornkamp Bjorn , "Dose-Finding Studies in Phase II: Introduction and Overview", Bornkamp Bjorn , John O'Quigley , Alexia lasonos , Bjorn Bornkamp, Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials, CRC Press, (20170101), pages 189 - 204, ISBN 978-1-4987-4610-6, XP093210047 | |
| OPPOSITION | - Bornkamp Björn, "Dose-Finding Studies in Phase II: Introduction and Overview", Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials, Chapman and Hall/CRC, (20170427), pages 189 - 204, doi:10.1201/9781315151984-11, ISBN 978-1-315-15198-4, XP093208967 | |
| OPPOSITION | - Claudia A Chiriboga, Swoboda Kathryn J, Darras Basil T, Iannaccone Susan T, Montes Jacqueline , Darryl Edd, De Vivo C, Norris Daniel A, Bennett ,C Frank, Bishop Kathie M, "Results from a phase 1 study of nusinersen (ISIS-SMNRx) in children with spinal muscular atrophy", Neurology, (20120210), doi:10.1212/WNL.0000000000002445, pages 890 - 897, XP055599706 | |
| OPPOSITION | - Holford Nick, "Pharmacodynamic principles and the time course of immediate drug effects", Translational and Clinical Pharmacology, (20170101), vol. 25, no. 4, doi:10.12793/tcp.2017.25.4.157, ISSN 2289-0882, pages 157 - 161, XP093208528 | |
| OPPOSITION | - Bayoumy Sherif, Verberk Inge M.W., Vermunt Lisa, Willemse Eline, Den Dulk Ben, Van Der Ploeg Ans T., Pajkrt Dasja, Nitz Elisa, Van Den Hout Johanna M.P., Van Der Post Julie, Wolf Nicole I., Beerepoot Shanice, Groen Ewout J.N., Tüngler Victoria, Teunissen Charlotte E., "Neurofilament light protein as a biomarker for spinal muscular atrophy: a review and reference ranges", CLINICAL CHEMISTRY AND LABORATORY MEDICINE, De Gruyter, DE, DE , (20240601), vol. 62, no. 7, doi:10.1515/cclm-2023-1311, ISSN 1434-6621, pages 1252 - 1265, XP093264361 | |
| OPPOSITION | - Finkel Richard S, Day John W, Ignacio Samuel, Pascual Pascual, Ryan Monique M, Mercuri Eugenio, De Vivo Darryl C, Montes Jacqueline, Gurgel-Giannetti Juliana, Monine Michael, Gambino Giulia, Makepeace Corinne, Foster Richard, Berger Zdenek, Chil St Jude, "DEVOTE Study Exploring Higher Dose of Nusinersen in Spinal Muscular Atrophy: Study Design and Part A Results", Journal of Neuromuscular Diseases, (20230908), vol. 10, doi:10.3233/JND-221667, ISSN 2214-3599, pages 813 - 823, XP093208510 | |
| OPPOSITION | - Finkel Richard S, Day John W, Ignacio Samuel, Pascual Pascual, Ryan Monique M, Mercuri Eugenio, De Vivo Darryl C, Montes Jacqueline, Gurgel-Giannetti Juliana, Monine Michael, Gambino Giulia, Makepeace Corinne, Foster Richard, Berger Zdenek, Chil St Jude, "DEVOTE Study Exploring Higher Dose of Nusinersen in Spinal Muscular Atrophy: Study Design and Part A Results", Journal of Neuromuscular Diseases, IOS Press, (20230908), vol. 10, doi:10.3233/JND-221667, ISSN 2214-3599, pages 813 - 823, XP093208510 | |
