Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
NCT ID: NCT04847232
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2690 participants
INTERVENTIONAL
2021-04-30
2024-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sodium Zirconium Cyclosilicate
Sodium Zirconium Cyclosilicate (SZC)
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).
Placebo
SZC Placebo
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.
Interventions
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Sodium Zirconium Cyclosilicate (SZC)
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).
SZC Placebo
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
3. Must be ≥ 18 years of age, at the time of signing the ICF.
4. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
5. Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
6. At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
7. Negative pregnancy test for female participants of childbearing potential
8. Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose
Exclusion Criteria
2. Presence of cardiac arrhythmias or conduction defects that require immediate treatment
3. Participants who have a pacemaker or implantable cardiac defibrillator
4. Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC
5. History of QT prolongation associated with other medications that required discontinuation of that medication
6. Congenital long QT syndrome
7. QTcF \> 550 msec
8. Atrial fibrillation requiring immediate/urgent intervention at screening or randomizations
9. Treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening or anticipated requiring chronic use of any of these agents during the study. If participant requires rescue therapy (potassium binder or dialysate S-K change during screening period), the participant will be screen failed
10. Participation in another clinical study with an investigational product, device, or non-standard hemodialysis procedure administered within one month before screening
11. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
12. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
13. Previous randomization in the present study
14. Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study
15. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof
16. Scheduled date for living donor kidney transplant
17. Sustained Ventricular Tachycardia \> 30 seconds requiring assessment / intervention
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Fishbane, Professor, MD
Role: PRINCIPAL_INVESTIGATOR
North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030
Locations
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Huntsville, Alabama, United States
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Mesa, Arizona, United States
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Bakersfield, California, United States
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Glendale, California, United States
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Granada Hills, California, United States
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Lynwood, California, United States
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San Diego, California, United States
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Vacaville, California, United States
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Victorville, California, United States
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Denver, Colorado, United States
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Bloomfield, Connecticut, United States
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Middlebury, Connecticut, United States
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Newark, Delaware, United States
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Fort Lauderdale, Florida, United States
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Tampa, Florida, United States
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Columbus, Georgia, United States
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Lawrenceville, Georgia, United States
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Statesboro, Georgia, United States
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Nampa, Idaho, United States
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Iowa City, Iowa, United States
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Baton Rouge, Louisiana, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Roseville, Michigan, United States
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Minneapolis, Minnesota, United States
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Brookhaven, Mississippi, United States
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Columbus, Mississippi, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Jersey City, New Jersey, United States
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Manhasset, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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New Bern, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bethlehem, Pennsylvania, United States
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Providence, Rhode Island, United States
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Spartanburg, South Carolina, United States
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České Budějovice, , Czechia
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Havlíčkův Brod, , Czechia
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Jilemnice, , Czechia
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Klatovy, , Czechia
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Liberec, , Czechia
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Kyoto, , Japan
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Batu Caves, , Malaysia
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Ipoh, , Malaysia
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Malacca, , Malaysia
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Chihuahua City, , Mexico
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Culiacán, , Mexico
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D.F, , Mexico
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Mazatlán, , Mexico
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Mexico City, , Mexico
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Piura, , Peru
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Gdansk, , Poland
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Słupsk, , Poland
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Tczew, , Poland
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Żyrardów, , Poland
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Kemerovo, , Russia
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Mytischi, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Penza, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Bratislava, , Slovakia
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Komárno, , Slovakia
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Košice, , Slovakia
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Lučenec, , Slovakia
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Púchov, , Slovakia
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Žilina, , Slovakia
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Alcalá de Henares, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Pamplona, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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Linkou District, , Taiwan
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New Taipei City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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Ratchathewi, , Thailand
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Dnipro, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Zaporizhzhia, , Ukraine
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Bristol, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Preston, , United Kingdom
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Salford, , United Kingdom
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Swansea, , United Kingdom
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Wolverhampton, , United Kingdom
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Biên Hòa, , Vietnam
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Da Nang, , Vietnam
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Huế, , Vietnam
Countries
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References
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Fishbane S, Dember LM, Jadoul M, Kovesdy CP, Guzman N, Kordzakhia G, Lisovskaja V, Sekar P, Wessman P, Al-Shurbaji A, Herzog CA. The randomized DIALIZE-Outcomes trial evaluated sodium zirconium cyclosilicate in hemodialysis. Kidney Int. 2025 Oct;108(4):686-694. doi: 10.1016/j.kint.2025.06.016. Epub 2025 Jul 4.
Fishbane S, Jadoul M, Dember L, Kovesdy CP, Al-Shurbaji A, Lisovskaja V, Sekar P, Katona B, Guzman N, Herzog C. Evaluation of the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with hyperkalaemia: protocol for the multicentre, randomised, controlled DIALIZE-Outcomes study. BMJ Open. 2023 May 25;13(5):e071309. doi: 10.1136/bmjopen-2022-071309.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Statistical Analysis Plan - Redacted
Other Identifiers
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2020-005561-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9487C00001
Identifier Type: -
Identifier Source: org_study_id
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