CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
2 other identifiers
interventional
885
33 countries
262
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Typical duration for phase_3
262 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2022
CompletedFirst Submitted
Initial submission to the registry
December 25, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
December 1, 2025
November 1, 2025
4.2 years
December 25, 2022
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157
Baseline up to Week 157
Proportion of Participants Who Experience Adverse Events (AEs)
Baseline up to Week 157
Proportion of Participants Who Use Concomitant Medications
Baseline up to Week 157
Study Arms (1)
Olezarsen
EXPERIMENTALParticipants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 153.
Interventions
Eligibility Criteria
You may qualify if:
- Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
- Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).
- A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (262)
LA Universal Research Center, Inc.
Los Angeles, California, 90057, United States
University of California, San Diego (UCSD)
San Diego, California, 92161, United States
Metabolic Institute of America
Tarzana, California, 91356, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Finlay Medical Research
Miami, Florida, 33126, United States
Innovia Research Center, Inc.
Miramar, Florida, 33027, United States
Harmony Clinical Research, Inc.
North Miami Beach, Florida, 33162, United States
R & B Medical Center LLC
Tampa, Florida, 33614, United States
VICIS Clinical Research
Tampa, Florida, 33615, United States
JSV Clinical Research Study, Inc.
Tampa, Florida, 33634, United States
Bayside Clinical Research
Trinity, Florida, 34655, United States
Centricity Research
Columbus, Georgia, 31904, United States
IACT Health
Columbus, Georgia, 31904, United States
Affinity Health
Oak Brook, Illinois, 60523, United States
St. Vincent Medical Group, Inc.
Carmel, Indiana, 46290, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, 40503, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213, United States
Grace Research, LLC
Bossier City, Louisiana, 71111, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
IRC Clinics
Towson, Maryland, 21204, United States
Massachusetts General Hospital Heart Center
Boston, Massachusetts, 02114, United States
University of Michigan- Endocrinology & Metabolism
Ann Arbor, Michigan, 48109, United States
Aa Mrc, Llc
Flint, Michigan, 48504, United States
Washington School of Medicine
St Louis, Missouri, 63110, United States
Bryan Medical Center
Lincoln, Nebraska, 68506, United States
Palm Research Center, Inc.
Las Vegas, Nevada, 89128, United States
Hudson County Clinical Trials Research Center
Union City, New Jersey, 07087, United States
Modern Medical
Brooklyn, New York, 33709, United States
NYU Langone Health
Mineola, New York, 11501, United States
Langone Medical Center
New York, New York, 10016, United States
Vagelos College of Physicians and Surgeons of Columbia University
New York, New York, 10032, United States
Orchard Park Family Practice
Orchard Park, New York, 14127, United States
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Kenneth Hilty
Greensboro, North Carolina, 27401, United States
Clinical Trials of America, LLC
Lenoir, North Carolina, 28645, United States
Lexington
Winston-Salem, North Carolina, 27103, United States
The Ohio State University
Columbus, Ohio, 43203, United States
Central Oklahoma Early Detection Center
Edmond, Oklahoma, 73034, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19014, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Walker Family Care
Little River, South Carolina, 29566, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, 37404, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Juno Research
Houston, Texas, 77040, United States
Pioneer Research Solutions
Houston, Texas, 77099, United States
Sante Clinical Research LLC
Kerrville, Texas, 78028, United States
FMC Science
Lampasas, Texas, 76550, United States
DCT- McAllen Primary Care, LLC
McAllen, Texas, 78503, United States
Texas Institute of Cardiology
McKinney, Texas, 75071, United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229, United States
Tranquil Clinical and Research Consulting Services
Webster, Texas, 77598, United States
Manassas Clinical Research
Manassas, Virginia, 20110, United States
York Clinical Research
Norfolk, Virginia, 23510, United States
WVU Heart and Vascular Institute
Morgantown, West Virginia, 26506, United States
CIPREC
Buenos Aires, C1061, Argentina
Fundacion Favaloro
Buenos Aires, C1093AAS, Argentina
Centro Medico Dra. Laura Maffei-Investigacion Clinica Aplicad
Buenos Aires, C1425AGC, Argentina
Glenny Corp SA
Buenos Aires, C1430CKE, Argentina
Instituto Medico DAMIC
Córdoba, X5003DCE, Argentina
Clinica FUSAVIM Privada
Villa María, X5900JKA, Argentina
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Royal Adelaide Hospital
Adelaide, 5000, Australia
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
Monash Medical Centre
Clayton, 3168, Australia
Dr Heart Pty Ltd
Woolloongabba, 4102, Australia
Universite Libre de Brussels (ULB)- Hopital Erasme
Brussels, 1070, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Centro Especializado em Cardiologia
Campinas, 13010-001, Brazil
Nucleo de Pesquisa Clinica S/S
Curitiba, 80730-150, Brazil
Hospital Universitario Walter Cantidio- UFC
Fortaleza, 60430-270, Brazil
Nucleo de Pasquisa em Cirurgia Vascular
Porto Alegre, 90035-903, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- FMUSP
São Paulo, 05403-000, Brazil
Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
São Paulo, CEP-05403-000, Brazil
CPQuali Pesquisa Clinica Ltda.
São Paulo, SP-01228-00, Brazil
MHAT- Blagoevgrad AD
Blagoevgrad, 2700, Bulgaria
Medical Center Doctor Staykov EOOD
Burgas, 8000, Bulgaria
Medical Center Diamedical 2013 OOD
Dimitrovgrad, 6400, Bulgaria
MHAT
Gabrovo, 5300, Bulgaria
MHAT Haskovo AD
Haskovo, 6300, Bulgaria
Multiprofile Hospital for Active Treament Pazardzhik, Cardiology Department
Pazardzhik, 4400, Bulgaria
SBAL "Special Medic" Ltd.
Plovdiv, 4000, Bulgaria
UHMAT Kaspela Ltd
Plovdiv, 4001, Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology
Plovdiv, 4002, Bulgaria
Medical Center Rusemed EOOD
Rousse, 7000, Bulgaria
UMHAT Kanev AD
Rousse, 7002, Bulgaria
DCC-1 Sliven Ltd.
Sliven, 8800, Bulgaria
Medical Center Smolyan Clinical Research OOD
Smolyan, 4700, Bulgaria
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
Sofia, 1000, Bulgaria
UMHAT Tsaritsa Yoanna ISUL- Clinic of Cardiology
Sofia, 1527, Bulgaria
Medical Center Endomedical
Sofia, 1606, Bulgaria
Medical Center Kalimat EOOD
Sofia, 1680, Bulgaria
MC Doctor Kalchev OOD
Sofia, 1700, Bulgaria
Medical Centre Synexus Sofia
Sofia, 1784, Bulgaria
UMHAT Sofiamed
Sofia, 1797, Bulgaria
MHAT Silven to MMA Sofia
Sofia, 8800, Bulgaria
Clinical of Cardiology
Stara Zagora, 6003, Bulgaria
Medical Center Zara-Med
Stara Zagora, 6010, Bulgaria
Diagnostic Consultative Center Equita (DCC Equita)
Varna, 9000, Bulgaria
Specialized Hospital for Active Treatment of Cardiology
Varna, 9020, Bulgaria
Medical Centre "Nevromedics" EOOD
Veliko Tarnovo, 5006, Bulgaria
Bluewater Clinical Research Group, Inc.
Sarnia, Ontario, N7T 4X3, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J2C5, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, Quebec, G1V 4W2, Canada
Institut de Recherches Cliniques de Montreal
Montreal, H2W 1T7, Canada
Toronto General Hospital
Toronto, M4C 3E7, Canada
MEDICUS SERVICES s.r.o.
Brandýs nad Labem, 250 01, Czechia
University Hospital Hradec Králové
Hradec Králové, 50005, Czechia
KardioBusak s.r.o.
Louny, 440 01, Czechia
EDUMED s.r.o.
Náchod, 547 01, Czechia
Fakultni nemocnice Ostrava
Ostrava, 70852, Czechia
Vseobecna fakultni nemocnice
Prague, 128 08, Czechia
Fakultni Nemocnice v Motole
Prague, 15006, Czechia
Praha Poliklinika Hurka
Prague, 158 00, Czechia
Endokrinologie Cerny Most s.r.o.
Prague, 19800, Czechia
Milan Kvapil s.r.o.
Příbram, 261 01, Czechia
AeskuLab k.s
Teplice, 415 01, Czechia
MU Dr. Nina Zemkova s.r.o. Interni Ambulance
Uherské Hradiště, 686 01, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus Universitet Hospital
Aarhus, 8200, Denmark
Esbjerg Hospital
Esbjerg, 6700, Denmark
Viborg Regional Hospital
Viborg, 8800, Denmark
Turku University Hospital
Turku, 20520, Finland
Louis Pradel Hospital
Bron, 69500, France
Chu Dijon Bourgogne
Dijon, 21079, France
Hôpitaux de Marseille
Marseille, 13005, France
Hopital Lapeyronie
Montpellier, 34295, France
AP-HP Hopital Pitie-Salpetriere
Paris, 75013, France
CHU de Nantes - Hôpital Nord Laennec
Saint-Herblain, 44093, France
CHRU de Strasbourg
Strasbourg, 67200, France
Groupement de Cooperation Sanitaire (GCS) ESLAN - Polyclinique Vauban
Valenciennes, 59300, France
GHM les Portes du Sud
Vénissieux, 69200, France
Charite- Universitaetsmedizin Berlin
Berlin, 13353, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, 1307, Germany
Forschungszentrum Ruhr
Witten, 58455, Germany
Evangelismos General Hospital Athens
Athens, 106 76, Greece
Hygeia Hospital
Athens, 15123, Greece
Lausmed Kft
Baja, 6500, Hungary
DRC Gyógyszervizsgáló Központ Korlátolt felelősségű társaság Balatonfüred
Balatonfüred, 8230, Hungary
Obudai Egeszsegugyyi Centrum
Budapest, H-1063, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Rakoczi Ferenc Korhaz
Miskolc, H-3529, Hungary
Dr. Vasas Szilard Haziorvosi Rendelo
Nyíregyháza, 4405, Hungary
Kardiologia Szakrendeles
Nyíregyháza, H-4400, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Vinaya Hospital and Research Centre
Mangalore, 575003, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Soroka Medical Center
Beersheba, 8410101, Israel
Bnai Zion Medical Center
Haifa, 3104802, Israel
The Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXII
Bergamo, 24127, Italy
Policlinico di Sant'Orsola
Bologna, 40138, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Sant' Anna e San Sebastiano" di Caserta
Caserta, 81100, Italy
Ospdale E. Bassini
Milan, 20092, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Policlinico
Palmero, 90127, Italy
Department of Translational and Precision Medicine
Rome, 00161, Italy
Klinikiniai Sprendimai, UAB
Kaunas, 49387, Lithuania
Saules Seimos Medicinos Centras
Kaunas, 49456, Lithuania
Kardiologijos ir reabilitacijos klinika, UAB
Klaipėda, 91131, Lithuania
University Malaya Medical Centre (UMMC)
Kuala Lumpur, 59100, Malaysia
Pulau Pinang Hospital
Pulau Pinang, 10990, Malaysia
Scientia Investigacion Clinical Sc
Chihuahua City, 31207, Mexico
Clinstile, S.A. de C.V.
Mexico City, 06700, Mexico
Centro de Investigacion Cardiometabolica S.C.
Mexico City, 20230, Mexico
Academic Medical Center
Amsterdam, 1105AZ, Netherlands
Gelre Ziekenhuizen
Apeldoorn, 7334 DZ, Netherlands
Ziekenhuis Rijnstate
Arnhem, 6815 AD, Netherlands
Het Van Weel-Bethesda Ziekenhuis
Dirksland, 3247 BW, Netherlands
Ziekenhuis Gelderse Vallei
Ede, 1001-5000, Netherlands
Bethesda Diabetes Research Center
Hoogeveen, 7909 AA, Netherlands
Radboud UMC
Nijmegen, 6525 EX, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Albert Schweitzer Ziekenhuis
Zwijndrecht, 3331 LZ, Netherlands
New Zealand Clinical Research
Auckland, 8011, New Zealand
Edgar Diabetes and Obesity Research Centre
Wellington, 6021, New Zealand
The Lipid Clinic (Oslo University Hospital)
Oslo, 424, Norway
Uniwersytecki Centrum Kliniczne, I Klinika Kardiologii
Gdansk, 80-952, Poland
Biokinetica Spolka Akcujna
Józefów, 05-410, Poland
Centrum Medyczne Salvia
Katowice, 40-772, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Clinical Best Solutions
Lublin, 20-078, Poland
ETG Lublin
Lublin, 20-412, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, 60-589, Poland
Osrodek Badan Klinicznych Metabolica
Tarnów, 33-100, Poland
Clinical Best Solutions Sp. z.o.o. Spolka Komandytowa
Warsaw, 02-793, Poland
Przychodnia Futuremeds Wroclaw
Wroclaw, 50-088, Poland
ETG Zamosc
Zamość, 22-400, Poland
Hospital Infante D. Pedro
Aveiro, 3814-501, Portugal
Hospital COF Tejo
Lisbon, 1350-352, Portugal
Hospital CUF Tejo
Lisbon, 1350-352, Portugal
Centro Hospitalar Universitario De Sao Joao
Porto, 4200-319, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E.
Santa Maria da Feira, 4520-211, Portugal
Cardioplus Center SRL
Baia Mare, 430123, Romania
Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
Bratislava, 831 06, Slovakia
Kardiologická ambulancia
Brezno, 97701, Slovakia
Cardio D&R, S.R.O. Kosice
Košice, 040 22, Slovakia
Human-Care s.r.o.
Košice, 04001, Slovakia
Vychodoslovensky Utsav srdcovych a cievnych chorob a.s.
Košice, 04011, Slovakia
Interna a diabetologicka ambulancia- IN- DRA- s.r.o.
Lučenec, 984 01, Slovakia
Diab sro
Rožňava, 048 01, Slovakia
Interna SK, s.r.o., Kardiologicka a interna ambulancia
Svidník, 08901, Slovakia
Nemocnica arm. generala L. Svobodu Svidnik, a.s
Svidník, 08901, Slovakia
Areteus sro
Trebišov, 075 01, Slovakia
Latros International
Bloemfontein, 9301, South Africa
Medi Clinic Vergelegen
Cape Town, 7130, South Africa
TREAD Research
Cape Town, 7500, South Africa
University of Cape Town
Cape Town, 7700, South Africa
Hospital Abente y Lago
A Coruña, 15001, Spain
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic De Barcelona
Barcelona, 08036, Spain
Hospital Universitari de Bellvitge
Barcelona, 8907, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Corporacio Sanitaria Parc Tauli- Hospital de Sabadell
Sabadell, 08208, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Universitari Sant Joan de Reus
Tarragona, 43204, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Sahlgrenska, University Hospital
Gothenburg, 413 45, Sweden
Karolinska University Hospital Huddinge
Stockholm, 14186, Sweden
Kaohsiung Medical University Ching-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Mackay Memorial Hospital
New Taipei City, 25160, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Shing Kong Wu Ho-Su Memorial Hospital
Taipei, 111, Taiwan
Ege University School of Medicine, Department of Cardiology
Izmir, 35040, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi
Konya, 42080, Turkey (Türkiye)
Hacettepe Üniversitesi Tıp Fakültesi
Sulhiye, 06100, Turkey (Türkiye)
Centre for Diabetes, Endocrinology and Metabolic Disease
Woodhurst, Chatsworth, 4092, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, England, HD3 3EA, United Kingdom
Waterloo Medical Care
Blackpool, FY4 3AD, United Kingdom
Hull Royal Infirmiry
Hull, HU3 2JZ, United Kingdom
Oak Tree Surgery and Pensilva Health Centre
Liskeard, PL14 3XA, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Newquay Health Centre
Newquay, TR7 1RQ, United Kingdom
The Adam Practice
Poole, BH16 5PW, United Kingdom
Sandwell and West Birmingham NHS Trust
West Bromwich, B71 4HU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 25, 2022
First Posted
January 12, 2023
Study Start
December 13, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.