A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
1 other identifier
interventional
2,494
23 countries
154
Brief Summary
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-sclerosis
Started Oct 2015
Longer than P75 for phase_3 multiple-sclerosis
154 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
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
October 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2023
CompletedResults Posted
Study results publicly available
January 30, 2024
CompletedJanuary 30, 2024
January 1, 2024
7.2 years
September 28, 2015
December 12, 2023
January 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Number of Participants Experiencing Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Adverse Events (AEs) of Special Interest
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC)
An absolute lymphocyte count (ALC) is a part of a blood test that measures the number of lymphocytes, a type of white blood cell, in the blood. Lymphocytes help fight infections and diseases. Reductions in ALC levels for participants in this study is expected and is a primary pharmacodynamic effect of RPC1063. LLN = Lower limit of normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in White Blood Cell Count (WBC)
A white blood cell count is a part of a blood test that measures the number of white blood cells in the blood. White blood cells help fight infections and diseases. LLN = Lower limit of normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC)
An absolute neutrophil count is a part of a blood test that measures the number of neutrophils, a type of white blood cell, in the blood. Neutrophils help fight infections and diseases.
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in Specific Liver Function Tests
The number of participants with laboratory abnormalities in specific liver tests above ULN by category. ULN = Upper Limit of Normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Electrocardiogram (ECG) Result Abnormalities
An electrocardiogram (ECG) measures electrical activity of the heart to detect cardiac problems.
From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
Number of Participants With Clinically Relevant Abnormalities in Vital Signs
Vital signs included body temperature, sitting heart rate/pulse (HR), sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP). Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and 60 months after first dose of study therapy
Number of Participants With Physical Examination Abnormalities
The number of participants with abnormal physical examination results. The assessments included abdominal, extremity, head, heart, lungs, neck, neurological non-MS, other and skin assessments. Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 84 months post first dose.
Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section. Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide). Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 3 months thereafter up until 78 months post first dose.
Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section. Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide).
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
The PWC-20 is a rater-administered 20-item scale to assess signs and symptoms of withdrawal. Twenty items are rated on a 4-point scale as not present (0 points), mild (1 point), moderate (2 points), or severe (3 points). The points from all items are calculated as a total score. Higher scores indicate more severe withdrawal symptoms.
1, 4, 7, 14, 21, and 90 days post last dose.
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
The HADS is a validated patient reported outcome for assessing anxiety and depression. It consists of 14 items in total, 7 items related to anxiety and 7 items related to depression. For each item patients select a statement (valued at 0 to 3 points) that closest matches their own feeling over the past week. Separate total scores for anxiety and depression are derived by adding up points. Total scores can range from 0 to 21 points. Higher scores indicate more severe anxiety and depression and scores of 8 to 10 are generally considered indicative of borderline anxiety/depression disorders and scores of 11 and higher are generally considered indicative of anxiety/depression disorders.
1, 4, 7, 14, 21, and 90 days post last dose.
Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
The ESS is a validated self administered questionnaire with 8 questions. Respondents rate on a 4-point scale (0 to 3) their chances of dozing off or falling asleep while engaged in 8 different activities. The ESS score is the sum of 8 item scores and can range from 0 to 24 points. Higher scores indicate more daytime sleepiness.
1, 4, 7, 14, 21, and 90 days post last dose.
Changes in Vital Sign Values From Last Day on Treatment
Vital signs included sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP).
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Secondary Outcomes (15)
Annualized Relapse Rate (ARR)
From first dose up until last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Time to First Relapse (TFR)
Overall: From first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); Visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
Number of Participants Who Were Relapse Free
From first dose to last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Average Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit
At 12 months post first dose and every 12 months thereafter up until 72 months post first dose.
Average Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit
At baseline and every 12 months thereafter up until 72 months post first dose.
- +10 more secondary outcomes
Study Arms (1)
1 mg RPC1063 (Ozanimod) oral capsule
EXPERIMENTAL1 mg RPC1063 (Ozanimod) oral capsule daily
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (175)
Local Institution - 115
Phoenix, Arizona, 85004, United States
Local Institution - 118
Phoenix, Arizona, 85013, United States
Local Institution - 110
Berkeley, California, 94705, United States
Local Institution - 103
Fresno, California, 93710, United States
Local Institution - 122
Long Beach, California, 90806, United States
Local Institution - 112
Sacramento, California, 95817, United States
Local Institution - 120
San Francisco, California, 94158, United States
Local Institution - 114
Maitland, Florida, 32751, United States
Local Institution - 123
Port Charlotte, Florida, 33952, United States
Local Institution - 124
Sunrise, Florida, 33351, United States
Local Institution - 147
Tampa, Florida, 33609, United States
Local Institution - 137
Golden Valley, Minnesota, 55422, United States
Local Institution - 170
Las Vegas, Nevada, 89106, United States
Local Institution - 143
Raleigh, North Carolina, 27607, United States
Local Institution - 107
Westerville, Ohio, 43801, United States
Local Institution - 144
Knoxville, Tennessee, 37922, United States
Local Institution - 138
Lubbock, Texas, 79410, United States
Local Institution - 179
Round Rock, Texas, 78681, United States
Local Institution - 141
Kirkland, Washington, 98034, United States
Local Institution - 907
Grodno, 230017, Belarus
Local Institution - 904
Homyel, 246029, Belarus
Local Institution - 902
Minsk, 220026, Belarus
Local Institution - 901
Minsk, 220114, Belarus
Local Institution - 903
Minsk, 220116, Belarus
Local Institution - 905
Vitebsk, 210023, Belarus
Local Institution - 906
Vitebsk, 210037, Belarus
Local Institution - 256
Bruges, 8000, Belgium
Local Institution - 255
Brussels, 1200, Belgium
Local Institution - 252
Montegnée, 4420, Belgium
Local Institution - 913
Banja Luka, 51000, Bosnia and Herzegovina
Local Institution - 911
Sarajevo, 71000, Bosnia and Herzegovina
Local Institution - 453
Sofia, 1113, Bulgaria
Local Institution - 454
Sofia, 1113, Bulgaria
Local Institution - 452
Sofia, 1309, Bulgaria
Local Institution - 456
Sofia, 1407, Bulgaria
Local Institution - 457
Sofia, 1431, Bulgaria
Local Institution - 460
Sofia, 1431, Bulgaria
Local Institution - 455
Sofia, 1606, Bulgaria
Local Institution - 923
Osijek, 31000, Croatia
Local Institution - 921
Zagreb, 10000, Croatia
Local Institution - 922
Zagreb, 10000, Croatia
Local Institution - 924
Zagreb, 10000, Croatia
Local Institution - 473
Tallinn, 10138, Estonia
Local Institution - 471
Tallinn, 10617, Estonia
Local Institution - 472
Tartu, EE-51014, Estonia
Local Institution - 301
Tbilisi, 0112, Georgia
Local Institution - 302
Tbilisi, 0160, Georgia
Local Institution - 304
Tbilisi, 0160, Georgia
Local Institution - 306
Tbilisi, 0177, Georgia
Local Institution - 303
Tbilisi, 0179, Georgia
Local Institution - 487
Leipzig, 04103, Germany
Local Institution - 496
Potsdam, 14471, Germany
Local Institution - 488
Ulm, 89079, Germany
Local Institution - 552
Athens, 10676, Greece
Local Institution - 553
Athens, 115 21, Greece
Local Institution - 551
Athens, 11525, Greece
Local Institution - 555
Thessaloniki, 57010, Greece
Local Institution - 352
Budapest, 1145, Hungary
Local Institution - 356
Budapest, 1204, Hungary
Local Institution - 354
Esztergom, 2500, Hungary
Local Institution - 358
Kistarcsa, 2143, Hungary
Local Institution - 351
Nyíregyháza, 4400, Hungary
Local Institution - 654
Catania, 95123, Italy
Local Institution - 653
Cefalù, 90015, Italy
Local Institution - 655
Milan, 20122, Italy
Local Institution - 659
Montichiari, 25018, Italy
Local Institution - 651
Roma, 00133, Italy
Local Institution - 562
Riga, LV-1015, Latvia
Local Institution - 561
Riga, LV1002, Latvia
Local Institution - 622
Kaunas, Kaunas County, LT-50009, Lithuania
Local Institution - 621
Klaipėda, LT-92288, Lithuania
Local Institution - 932
Chisinau, 2004, Moldova
Local Institution - 931
Chisinau, 2028, Moldova
Local Institution - 933
Chisinau, 2028, Moldova
Local Institution - 511
Christchurch, 8011, New Zealand
Local Institution - 510
Hamilton, 2001, New Zealand
Local Institution - 434
Warsaw, Masovian Voivodeship, 05-077, Poland
Local Institution - 401
Bialystok, 15-420, Poland
Local Institution - 423
Bydgoszcz, 85-795, Poland
Local Institution - 406
Czeladź, 41-250, Poland
Local Institution - 405
Gdansk, 80-803, Poland
Local Institution - 432
Jarosław, 37-500, Poland
Local Institution - 417
Katowice, 40-555, Poland
Local Institution - 427
Katowice, 40-595, Poland
Local Institution - 426
Katowice, 40-650, Poland
Local Institution - 407
Katowice, 40-749, Poland
Local Institution - 424
Kielce, 25-726, Poland
Local Institution - 404
Konstancin-Jeziorna, 05-510, Poland
Local Institution - 414
Krakow, 31-305, Poland
Local Institution - 411
Lódzkie, 90-324, Poland
Local Institution - 429
Lublin, 20-059, Poland
Local Institution - 412
Lublin, 20-718, Poland
Local Institution - 420
Lublin, 20-718, Poland
Local Institution - 431
Mazowieckie, 02-097, Poland
Local Institution - 415
Olsztyn, 10-561, Poland
Local Institution - 421
Plewiska, 62-064, Poland
Local Institution - 425
Pomorskie, 80-299, Poland
Local Institution - 408
Poznan, 60-355, Poland
Local Institution - 418
Poznan, 61-853, Poland
Local Institution - 433
Rybnik, 44-200, Poland
Local Institution - 435
Rzeszów, 35-326, Poland
Local Institution - 419
Szczecin, 70-111, Poland
Local Institution - 402
Warminsko-mazurskie, 10-443, Poland
Local Institution - 410
Warsaw, 00-739, Poland
Local Institution - 428
Warsaw, 01-697, Poland
Local Institution - 422
Warsaw, 02-507, Poland
Local Institution - 403
Warsaw, 02-957, Poland
Local Institution - 413
Warsaw, 04-141, Poland
Local Institution - 772
Braga, 4710-243, Portugal
Local Institution - 775
Coimbra, 3000-075, Portugal
Local Institution - 773
Torres Vedras, 2560-280, Portugal
Local Institution - 503
Brasov, 500123, Romania
Local Institution - 509
Bucharest, 022328, Romania
Local Institution - 504
Bucharest, 20125, Romania
Local Institution - 520
Bucharest, 20125, Romania
Local Institution - 502
Campulung Muscel, 115100, Romania
Local Institution - 508
Cluj-Napoca, 400012, Romania
Local Institution - 501
Cluj-Napoca, 400347, Romania
Local Institution - 507
Constanța, 900123, Romania
Local Institution - 506
Timișoara, 300736, Romania
Local Institution - 602
Belgrade, 11000, Serbia
Local Institution - 603
Belgrade, 11000, Serbia
Local Institution - 604
Belgrade, 11000, Serbia
Local Institution - 601
Belgrade, 11080, Serbia
Local Institution - 605
Kragujevac, 34000, Serbia
Local Institution - 606
Niš, 18000, Serbia
Local Institution - 946
Bratislava, 833 05, Slovakia
Local Institution - 942
Lučenec, 984 01, Slovakia
Local Institution - 945
Trnava, 91775, Slovakia
Local Institution - 953
Pretoria, 0040, South Africa
Local Institution - 756
Barcelona, 08003, Spain
Local Institution - 758
Barcelona, 08035, Spain
Local Institution - 761
Bilbao, 48013, Spain
Local Institution - 759
Donostia / San Sebastian, 20014, Spain
Local Institution - 760
Girona, 17190, Spain
Local Institution - 757
Madrid, 28006, Spain
Local Institution - 754
Majadahonda, 28222, Spain
Local Institution - 764
Pamplona/ Navarra, 31008, Spain
Local Institution - 766
Sant Joan Despí, 08970, Spain
Local Institution - 755
Sevillla, 41009, Spain
Local Institution - 767
Valencia, 46010, Spain
Local Institution - 752
Valencia, 46026, Spain
Local Institution - 780
Gothenburg, SE-413 45, Sweden
Local Institution - 823
Cherkasy, 18009, Ukraine
Local Institution - 830
Chernihiv, 14001, Ukraine
Local Institution - 805
Chernihiv, 14029, Ukraine
Local Institution - 813
Chernivtsi, 58018, Ukraine
Local Institution - 802
Dnipropetrovsk, 49027, Ukraine
Local Institution - 815
Dnipropetrovsk, 49027, Ukraine
Local Institution - 801
Ivano-Frankivsk, 76008, Ukraine
Local Institution - 829
Ivano-Frankivsk, 76018, Ukraine
Local Institution - 814
Kharkiv, 61018, Ukraine
Local Institution - 827
Kharkiv, 61022, Ukraine
Local Institution - 832
Kharkiv, 61176, Ukraine
Local Institution - 811
Kherson, 73000, Ukraine
Local Institution - 822
Kyiv, 03115, Ukraine
Local Institution - 803
Kyiv, 04107, Ukraine
Local Institution - 818
Kyiv, 3110, Ukraine
Local Institution - 824
Kyiv, 3110, Ukraine
Local Institution - 817
Lutsk, 43024, Ukraine
Local Institution - 812
Lviv, 79010, Ukraine
Local Institution - 821
Lviv, 79044, Ukraine
Local Institution - 810
Odesa, 65009, Ukraine
Local Institution - 831
Odesa, 65025, Ukraine
Local Institution - 804
Odesa, 65117, Ukraine
Local Institution - 826
Poltava, 36011, Ukraine
Local Institution - 820
Uzhhorod, 88018, Ukraine
Local Institution - 809
Vinnytsia, 21005, Ukraine
Local Institution - 825
Zaporizhia, 69065, Ukraine
Local Institution - 828
Zaporizhzhia, 69600, Ukraine
Local Institution - 806
Zaporizhzhya, 69035, Ukraine
Local Institution - 819
Zhytomyr, 10008, Ukraine
Local Institution - 965
East Sussex, BN2 5BE, United Kingdom
Local Institution - 963
Inverness, IV2 3UJ, United Kingdom
Local Institution - 964
Sheffield, S10 2JF, United Kingdom
Related Publications (5)
Selmaj KW, Steinman L, Comi G, Bar-Or A, Arnold DL, Hartung HP, Montalban X, Havrdova EK, Sheffield JK, Krakovich A, Cheng CY, Riolo JV, Pachai C, Thorpe A, DeBoer E, Kappos L, Cohen JA, Cree BA. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial. Mult Scler. 2025 Nov;31(13):1557-1571. doi: 10.1177/13524585251382796. Epub 2025 Nov 5.
PMID: 41190505DERIVEDCohen JA, Arnold DL, DeLuca J, Hartung HP, Kappos L, Comi G, Selmaj K, Steinman L, Bar-Or A, Montalban X, Havrdova EK, Sheffield JK, Pachai C, Cheng CY, Riolo JV, Cree BA. Brain atrophy and associations with long-term disability and cognitive function in participants with relapsing multiple sclerosis treated with ozanimod: Results from phase 3 and open-label extension trials. Mult Scler. 2025 Sep;31(10):1218-1230. doi: 10.1177/13524585251355842. Epub 2025 Jul 23.
PMID: 40698614DERIVEDRegueiro M, Siegmund B, Horst S, Moslin R, Charles L, Petersen A, Tatosian D, Wu H, Lawlor G, Fischer M, D'Haens G, Colombel JF. Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis. Inflamm Bowel Dis. 2025 Apr 10;31(4):1010-1017. doi: 10.1093/ibd/izae136.
PMID: 39018016DERIVEDNaismith RT, Cohen JA, Bar-Or A, Comi G, Selmaj KW, Hartung HP, Sheffield JK, Krakovich A, Tatosian D, Cheng CY, Reardon J, Khaychuk V, Riolo JV, Silva D, Cree BA. Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial. Mult Scler. 2024 Feb;30(2):177-183. doi: 10.1177/13524585231216854. Epub 2023 Dec 21.
PMID: 38130041DERIVEDCree BAC, Maddux R, Bar-Or A, Hartung HP, Kaur A, Brown E, Li Y, Hu Y, Sheffield JK, Silva D, Harris S. SARS-CoV-2 vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis. Ann Clin Transl Neurol. 2023 Oct;10(10):1725-1737. doi: 10.1002/acn3.51862. Epub 2023 Aug 7.
PMID: 37550942DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 15, 2015
Study Start
October 16, 2015
Primary Completion
January 5, 2023
Study Completion
January 5, 2023
Last Updated
January 30, 2024
Results First Posted
January 30, 2024
Record last verified: 2024-01