A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline
3 other identifiers
interventional
1,400
10 countries
262
Brief Summary
The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
Longer than P75 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
First Submitted
Initial submission to the registry
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
October 22, 2024
CompletedStudy Start
First participant enrolled
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
November 20, 2025
November 1, 2025
4.4 years
October 21, 2024
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)
Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).
Baseline to Time to Event up to Week 255
Secondary Outcomes (11)
Change from Baseline in Clinical Dementia Rate Box Score (SB)
Baseline, Week 255
Change from Baseline in Montreal Cognitive Assessment (MoCA)
Baseline, Week 255
Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory
Baseline, Week 255
Change from Baseline in the Continuous Paired Associate Learning (CPAL)
Baseline, Week 255
Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem
Baseline, Week 255
- +6 more secondary outcomes
Study Arms (2)
Remternetug
EXPERIMENTALRemternetug administered subcutaneously (SC).
Placebo
PLACEBO COMPARATORPlacebo administered SC.
Interventions
Eligibility Criteria
You may qualify if:
- Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
- Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
- Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
- Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
- If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
You may not qualify if:
- Have dementia or significant other neurological disease that can affect cognition.
- Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
- Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
- Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
- Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study.
- Have any contraindications for magnetic resonance imaging (MRI).
- Have a centrally read MRI that does not meets study entry criteria.
- Prior or Current Therapies
- Have ever had prior treatment with a passive anti-amyloid immunotherapy.
- Have received active immunization against Aβ in any other study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (262)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
MD First Research - Chandler
Chandler, Arizona, 85286, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Banner Alzheimer's Institute Tucson
Tucson, Arizona, 85718, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Care Access - Huntington Beach
Huntington Beach, California, 92648, United States
Inglewood Clinical
Inglewood, California, 90301, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
Riverside Clinical
Riverside, California, 92506, United States
Clinical Trials Research
Sacramento, California, 95821, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Sharp Neurocognitive Research Center
San Diego, California, 92123, United States
Ray Dolby Brain Health Center
San Francisco, California, 94114, United States
The Neuron Clinic - San Marcos
San Marcos, California, 92069, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
California Neuroscience Research, LLC
Sherman Oaks, California, 91403, United States
Care Access - Aurora
Aurora, Colorado, 80012, United States
Mountain Neurological Research Center
Basalt, Colorado, 81621, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113, United States
Invicro
New Haven, Connecticut, 06510, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
VIN - Aventura
Aventura, Florida, 33180, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
K2 Medical Research WINTER GARDEN
Clermont, Florida, 34711, United States
TecTum Research
Davie, Florida, 33024, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159, United States
ClinCloud
Maitland, Florida, 32751, United States
K2 Medical Research ORLANDO
Maitland, Florida, 32751, United States
ClinCloud
Melbourne, Florida, 32940, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
VIN-Andrew Lerman
Miami, Florida, 33133, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, 34997, United States
Axiom Brain Health LLC
Tampa, Florida, 33609, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Care Access - Tampa
Tampa, Florida, 33625, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Conquest Research
Winter Park, Florida, 32789, United States
Columbus Memory Center, LLC
Columbus, Georgia, 31909, United States
Care Access - Decatur
Decatur, Georgia, 30030, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Care Access - Arlington Heights
Arlington Heights, Illinois, 60005, United States
Re:Cognition Health - Chicago
Chicago, Illinois, 60611, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46227, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
Cedar Valley Medical Specialists
Waterloo, Iowa, 50701, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Acadia Hospital
Bangor, Maine, 04401, United States
Care Access - Baltimore
Baltimore, Maryland, 21213, United States
Adams Clinical Boston
Boston, Massachusetts, 02116, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Care Access - Quincy
Quincy, Massachusetts, 02169, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472, United States
Revival Research Institute, LLC
Dearborn, Michigan, 48126, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130, United States
Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi, 39401, United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Care Access - Hoboken
Hoboken, New Jersey, 07030, United States
The Cognitive and Research Center of New Jersey - Ridgewood
Ridgewood, New Jersey, 07450, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
IMA Clinical Research
Albuquerque, New Mexico, 87109, United States
Care Access - Charlotte
Charlotte, North Carolina, 28210, United States
Medication Management
Greensboro, North Carolina, 27405, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Care Access - Lima
Lima, Ohio, 45805, United States
North Star Medical Research
Middleburg Heights, Ohio, 44130, United States
Summit Headlands
Portland, Oregon, 97210, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Tribe Clinical Research, LLC- Greenville
Greenville, South Carolina, 29607, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Neurology Clinic, P.C.
Cordova, Tennessee, 38018, United States
Genesis Neuroscience Clinic
Knoxville, Tennessee, 37909, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Kerwin Medical Center - Oak Cliff
Dallas, Texas, 75216, United States
Kerwin Medical Center
Dallas, Texas, 75231, United States
Care Access - Georgetown
Georgetown, Texas, 78633, United States
Care Access - Houston
Houston, Texas, 77054, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Next Level Urgent Care
Houston, Texas, 77057, United States
El Faro Health and Therapeutics
Rio Grande City, Texas, 78582, United States
Central Texas Neurology Consultants, PA
Round Rock, Texas, 78681, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Care Access - Arlington 2
Arlington, Virginia, 22206, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
Eastern Virginia Medical School (EVMS) Medical Group
Norfolk, Virginia, 23510, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
USC Clinical Trials Sunshine Coast
Birtinya, 4575, Australia
Emeritus Research
Botany, 2019, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Emeritus Research
Camberwell, 3124, Australia
GenesisCare - Maitland
East Maitland, 2323, Australia
The University of Queensland
Herston, 4029, Australia
Ipswich Hospital
Ipswich, 4305, Australia
Austin Health
Ivanhoe, 3079, Australia
Southern Neurology
Kogarah, 2217, Australia
KARA Institute for Neurological Diseases
Macquarie Park, 2113, Australia
HammondCare
Malvern, 3144, Australia
Fusion Clinical Research
Norwood, 5067, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
USC Clinical Trials Brisbane (South Bank)
South Brisbane, 4101, Australia
St Vincent's Hospital
Sydney, 2010, Australia
The Queen Elizabeth Hospital
Woodville, 5011, Australia
Ecogene-21 - Cmas
Chicoutimi, G7H 0S7, Canada
MoCA Research and Innovation Inc.
Greenfield Park, J4V 2J2, Canada
OCT Research ULC
Kelowna, V1Y 1Z9, Canada
Alpha Recherche Clinique - Lévis
Lévis, G6V 0C9, Canada
Clinique Mémoire de Montréal
Montreal, H3G 1H9, Canada
Genge Partners
Montreal, H4A 3T2, Canada
Ottawa Memory Clinic
Ottawa, K1Z 1G3, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, K9H 2P4, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, J1J 2G2, Canada
Toronto Memory Program
Toronto, M3B 2S7, Canada
Sunnybrook Research Institute
Toronto, M4N 3M5, Canada
Baycrest Health Sciences
Toronto, M6A 2E1, Canada
Diex Recherche Inc. Division Victoriaville
Victoriaville, G6P 3Z8, Canada
The Medical Arts Health Research Group - West Vancouver
West Vancouver, V7T 1C5, Canada
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, 100071, China
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088, China
The First Hospital of Jilin University
Changchun, 100012, China
Xiangya Hospital Central South University
Changsha, 410008, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
Guangzhou First People's Hospital
Guangzhou, 510180, China
Guangzhou Medical University 2nd Hospital
Guangzhou, 510260, China
Zhujiang Hospital
Guangzhou, 510280, China
Anhui Provincial Hospital
Hefei, 230036, China
Jinan Central Hospital
Jinan, 250013, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330000, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Nanjing Brain Hospital
Nanjing, 210029, China
Sir Run Run Hospital of Nanjing Medical University
Nanjing, 211166, China
Shanghai Sixth People's Hospital
Shanghai, 200030, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200135, China
Pudong New Area People's Hospital Shanghai
Shanghai, 201200, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Shaanxi provincial people's hospital
Xi'an, 710068, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, 710077, China
Xianyang Hospital of Yan'an University
Xianyang, 712000, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221006, China
Xuzhou Central Hospital
Xuzhou, 221018, China
Zigong First People's Hospital
Zigong, 643000, China
The University of Tokyo Hospital
Bunkyō City, 113-8655, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chūōku, 103-0027, Japan
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Fukuwa Clinic
Chūōku, 104-0031, Japan
Tokyo Asbo Clinic
Chūōku, 104-0031, Japan
Kawashima Neurology Clinic
Fujisawa, 251-0038, Japan
UNB Sumiyoshi Jinjamae Clinic
Fukuoka, 812-0018, Japan
Boocs Clinic Fukuoka
Fukuoka, 812-0025, Japan
P-One Clinic
Hachiōji, 192-0071, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, 670-8560, Japan
Saiseikai Imabari Hospital
Imabari, 799-1592, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Showa General Hospital
Kodaira, 187-8510, Japan
Tatsuoka Neurology Clinic
Kyoto, 600-8811, Japan
Sakurazaka Clinic SophyAnce
Minatoku, 106-0032, Japan
Iwata Neurosurgery Clinic
Osaka, 536-0007, Japan
National Center for Geriatrics and Gerontology
Ōbu, 474-8511, Japan
Kanto Central Hospital
Setagaya-ku, 158-8531, Japan
Samoncho Clinic
Shinjuku, 160-0017, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, 160-0004, Japan
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, 160-0008, Japan
Higashi Shinjuku Clinic
Shinjuku-ku, 169-0072, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 565-0853, Japan
Tokyo Metropolitan Geriatric Hospital
tabashi City, 173-0015, Japan
Tachikawa Hospital
Tachikawa, 190-8531, Japan
Takatsuki Hospital
Takatsuki-shi, 569-1192, Japan
Wako Hospital
Wako, 351-0111, Japan
SCB Research Center
Bayamón, 00961, Puerto Rico
Caribbean Medical Research Center
San Juan, 00918, Puerto Rico
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918, Puerto Rico
Pusan National University Hospital
Busan, 49241, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273, South Korea
Ewha Womans University Seoul Hospital
Gangseo-gu, 07804, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Jeju National University Hospital
Jeju City, 63241, South Korea
Gachon University Gil Medical Center
Namdong-gu, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Barcelonabeta Brain Research Center
Barcelona, 08005, Spain
Fundació ACE
Barcelona, 08028, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Policlinica Gipuzkoa
San Sebastián, 20014, Spain
Hospital Victoria Eugenia
Seville, 41009, Spain
Changhua Christian Hospital
Changhua County, 50006, Taiwan
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
Douliu, 640, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, 236, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
ReMind UK
Bath, BA1 3NG, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, B16 8LT, United Kingdom
Layton Medical Centre
Blackpool, FY3 7EN, United Kingdom
Scottish Brain Sciences
Edinburgh, EH12 5PJ, United Kingdom
St Pancras Clinical Research
London, EC2Y 8EA, United Kingdom
NIHR Manchester Clinical Research Facility
Manchester, M13 9WL, United Kingdom
NeuroClin
Motherwell, ML1 4UF, United Kingdom
Roborough Surgery
Plymouth, PL6 6PH, United Kingdom
Homecroft Surgery
Redruth, TR16 4ET, United Kingdom
Abbeywell Surgery
Romsey, SO51 7QN, United Kingdom
Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Marine Lake Medical Practice
West Kirby, CH48 5AA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2024
First Posted
October 22, 2024
Study Start
October 24, 2024
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
October 1, 2030
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.