SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

NCT ID: NCT03876457

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2023-11-16

Brief Summary

SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.

Detailed Description

SELECT 2 is a prospective, phase III randomized, international, multicenter, assessor-blinded controlled trial evaluating the efficacy and safety of thrombectomy in patients with large core on either CT or advanced perfusion imaging treated within 0-24 hours from last known well.

Patients with the final diagnosis of an acute ischemic stroke due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both within 0-24 hrs from last known well will be randomized in a 1:1 ratio into thrombectomy plus medical management vs medical management alone. Patient outcomes will be measured at baseline, 24 hours post, discharge, 30 days and 90 days.

The primary endpoint is the Modified Rankin Scale (mRS) at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS. Secondary outcomes are favorable clinical outcomes: mRS score of 0-2, safety outcomes such the incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST) and Imaging endpoints such as infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization. CT images will be read by iSchemaView automated ASPECTS as well as by a physician. In cases where there is disagreement, the physician reading will override the automated software reading. CT/MR perfusion images with mismatch determination will be read by iSchemaView automated RAPID software. All the images will be adjudicated by a blinded core lab at the University of Texas-Medical School at Houston.

A maximum of 560 patients will be randomized across the study sites. Covariate adaptive randomization will be used to balance the distribution of important variables. Interim analyses will be conducted at 200 and 380 patients, at which time the study may stop for efficacy or futility.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endovascular Thrombectomy plus Medical Management

Group Type: EXPERIMENTAL

Endovascular Thrombectomy

Intervention Type: DEVICE

Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them.

Medical Management

Intervention Type: OTHER

Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.

Medical Management

Group Type: ACTIVE_COMPARATOR

Medical Management

Intervention Type: OTHER

Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.

Interventions

Endovascular Thrombectomy

Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them.

Intervention Type: DEVICE

Medical Management

Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke

2. NIH Stroke Scale Score (NIHSS) ≥ 6

3. Last known well to groin puncture or medical management between 0 to 24 hours

4. Pre-stroke modified Rankin Scale score (mRS) of 0-1

5. Eligible for thrombectomy or medical management

6. Signed Informed Consent obtained

7. Subject willing to comply with the protocol follow-up requirements

8. Anticipated life expectancy of at least 3 months

1. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA

2. Large infarct-core lesion on at least one of the following:

• 2.1. Non-Contrast CT (ASPECTS of 3-5),
• 2.2. CT perfusion (rCBF<30% ≥50cc),
• 2.3. MRI-DWI (ADC<620 ≥50cc)

Exclusion Criteria

1. Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)

2. Co-morbid psychiatric or medical illnesses that would confound the neurological assessments

3. Treatment with thrombolytic agent beyond 4.5 hours from last known well

4. Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the following:

• 1) age >80,
• 2) current anticoagulant use,
• 3) history of diabetes AND prior stroke,
• 4) NIHSS >25,
• 5) ischemic involvement of > 1/3 MCA territory

5. Current participation in another investigational drug or device study.

1. Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume <50 cc on perfusion imaging

2. Patients with very large core on non-contrast CT i.e. ASPECTS ≤ 2

3. Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation

4. A significant mass effect with midline shift

5. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection

6. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device

7. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).

8. Signs of established infarct and large area of cerebral edema on non-contrast CT

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Neurovascular

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amrou Sarraj

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amrou Sarraj, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University - University Hospitals Cleveland Medical Center

(Australia and Oceania) Bruce CV Campbell, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

(Europe) Marc Ribo, MD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron University Hospital, Barcelona

Locations

Kaiser Permanente

Los Angeles, California, United States

Baptist Health

Jacksonville, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Ascension St. Vincent Hospital

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Spectrum Health Hospital

Grand Rapids, Michigan, United States

Westchester Medical Center

Valhalla, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Riverside Methodist Hospital - OhioHealth

Columbus, Ohio, United States

Abington Jefferson Health

Abington, Pennsylvania, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Semmes Murphey Clinic - University of Tennessee Health Science Center

Memphis, Tennessee, United States

Dell Seton Medical Center at the University of Texas at Austin

Austin, Texas, United States

Valley Baptist Medical Center

Harlingen, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Ascension Wisconsin

Milwaukee, Wisconsin, United States

Liverpool Hospital - South Western Sydney Clinical School

Liverpool, New South Wales, Australia

The Royal Adelaide Hospital (RAH)

Adelaide, South Australia, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

University of Alberta

Edmonton, Alberta, Canada

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Christchurch Hospital

Christchurch, Canterbury, New Zealand

Hospital Universitario Germans Trias i Pujol

Badalona, , Spain

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Universität Basel

Basel, , Switzerland

Countries

United States; Australia; Canada; New Zealand; Spain; Switzerland

References

Sarraj A, Blackburn S, Abraham MG, Hussain MS, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Sitton CW, Pujara DK, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Vora N, Arenillas JF, Alfonso ML, Ramos Araque ME, Tsai JP, Abdulrazzak MA, Kozak O, Yan B, Mitchell PJ, Cordato DJ, Manning NW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Merchan AJP, Gandhi CD, Al-Mufti F, Samaniego EA, Maali L, Qureshi A, Lechtenberg CG, Slavin S, Rosterman L, Gibson D, Wallace AN, Sahlein D, Perez de la Ossa N, Hernandez Perez M, Schaafsma JD, Blasco J, Renu A, Sangha N, Warach S, Kleinig TJ, Mullen M, Elijovich L, Shaker F, Al-Shaibi FK, Johns H, Duncan KR, Opaskar A, Popovic MJ, Altose M, Ray A, Xiong W, Sunshine J, DeGeorgia M, Nguyen TN, Fifi JT, Tjoumakaris S, Jabbour P, Pereira VM, Lansberg MG, Albers GW, Sila C, Bambakidis N, Davis S, Wechsler L, Hill MD, Grotta JC, Ribo M, Hassan AE, Campbell BC; SELECT2 Investigators. General vs Nongeneral Anesthesia for Endovascular Thrombectomy in Patients With Large Core Strokes: A Prespecified Secondary Analysis of SELECT2 Trial. Neurology. 2025 Jul 22;105(2):e213819. doi: 10.1212/WNL.0000000000213819. Epub 2025 Jun 26.

Reference Type: DERIVED

PMID: 40570276 (View on PubMed)

Yogendrakumar V, Campbell BCV, Johns HT, Churilov L, Ng FC, Sitton CW, Hassan AE, Abraham MG, Ortega-Gutierrez S, Hussain MS, Chen M, Kasner SE, Sharma G, Guha P, Pujara DK, Shaker F, Lansberg MG, Wechsler LR, Nguyen TN, Fifi JT, Hill MD, Ribo M, Parsons MW, Davis SM, Grotta JC, Albers GW, Sarraj A; SELECT2 Investigators. Association of Ischemic Core Hypodensity With Thrombectomy Treatment Effect in Large Core Stroke: A Secondary Analysis of the SELECT2 Randomized Controlled Trial. Stroke. 2025 Jun;56(6):1366-1375. doi: 10.1161/STROKEAHA.124.048899. Epub 2025 Mar 28.

Reference Type: DERIVED

PMID: 40151939 (View on PubMed)

Ortega-Gutierrez S, Rodriguez-Calienes A, Pujara D, Sitton C, Galecio-Castillo M, Hassan AE, Abraham MG, Chen M, Blackburn S, Kasner SE, Olalde H, Ghannam M, Hussain MS, Leira EC, Martinez-Galdamez M, Shaban A, Tsai JP, Roeder H, Gudenkauf JC, Budzik R, Vora N, Hanel RA, Aghaebrahim A, Colgan F, de Miquel MA, Gandhi CD, Al-Mufti F, Blasco J, San Roman Manzanera L, Herial NA, Manning NW, Cheung A, Kozak O, Yan B, Mitchell PJ, Ebersole K, Toth G, Gooch M, Gibson D, Sahlein DH, Amuluru K, Abdulrazzak MA, Duncan K, Defta D, Shaker F, Al-Shaibi F, Ray A, Sunshine J, Hu YC, Burkhardt JK, Mir O, Alenzi B, Kass-Hout T, Gupta R, Tjoumakaris SI, Jabbour PM, Nguyen TN, Fifi JT, Pereira VM, Bambakidis N, Hill MD, Grotta JC, Ribo M, Campbell BCV, Samaniego EA, Sarraj A. Endovascular Thrombectomy for Extracranial Internal Carotid Artery Occlusions With Large Ischemic Strokes: Insights From the SELECT2 Trial. Neurology. 2025 Feb 25;104(4):e210269. doi: 10.1212/WNL.0000000000210269. Epub 2025 Jan 27.

Reference Type: DERIVED

PMID: 39869840 (View on PubMed)

Tsai JP, Nguyen TN, Pujara DK, Fifi JT, Sundararajan S, Schaafsma JD, Perez de la Ossa N, Abraham MG, Chen M, Hussain MS, Ortega-Gutierrez S, Johns HT, Duncan KR, Churilov L, Lechtenberg CG, Slavin SJ, Opaskar A, de Lera M, Lara-Rodriguez B, Quesada H, Fournier LE, Defta DM, Shaker F, Sitton CW, Sharrief AZ, Grotta JC, Hill MD, Ribo M, Hassan AE, Campbell BCV, Sila C, Tjoumakaris SI, Sarraj A; for SELECT2 Investigators. Sex-Based Differences in Endovascular Thrombectomy Outcomes for Large Ischemic Stroke: A SELECT2 Subanalysis. Stroke. 2025 Feb;56(2):294-304. doi: 10.1161/STROKEAHA.124.049307. Epub 2025 Jan 2.

Reference Type: DERIVED

PMID: 39744837 (View on PubMed)

Chen H, Malhotra A, Gandhi D. Thrombectomy for Large Strokes. N Engl J Med. 2024 Jul 25;391(4):378-379. doi: 10.1056/NEJMc2406965. No abstract available.

Reference Type: DERIVED

PMID: 39047249 (View on PubMed)

Sarraj A, Hill MD, Hussain MS, Abraham MG, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Pujara DK, Johns H, Blackburn S, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Arenillas JF, Tsai JP, Kozak O, Cordato DJ, Hanel RA, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Maali L, Gibson D, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Sitton CW, Nguyen T, Fifi JT, Jabbour P, Furlan A, Lansberg MG, Tsivgoulis G, Sila C, Bambakidis N, Davis S, Wechsler L, Albers GW, Grotta JC, Ribo M, Campbell BC, Hassan AE; SELECT2 Investigators; SELECT2 Collaborators; Vora N, Manning NW, Cheung A, Aghaebrahim AN, Paipa Merchan AJ, Sahlein D, Requena Ruiz M, Elijovich L, Arthur A, Al-Shaibi F, Samaniego EA, Duncan KR, Opaskar A, Ray A, Xiong W, Sunshine J, DeGeorgia M, Tjoumakaris S, Mendes Pereira V; SELECT2 Collaborators. Endovascular Thrombectomy Treatment Effect in Direct vs Transferred Patients With Large Ischemic Strokes: A Prespecified Analysis of the SELECT2 Trial. JAMA Neurol. 2024 Feb 8;81(4):327-35. doi: 10.1001/jamaneurol.2024.0206. Online ahead of print.

Reference Type: DERIVED

PMID: 38363872 (View on PubMed)

Sarraj A, Abraham MG, Hassan AE, Blackburn S, Kasner SE, Ortega-Gutierrez S, Hussain MS, Chen M, Johns H, Churilov L, Pujara DK, Shaker F, Maali L, Cardona Portela P, Herial NA, Gibson D, Kozak O, Arenillas JF, Yan B, Perez de la Ossa N, Sundararajan S, Hu YC, Cordato DJ, Manning NW, Hanel RA, Aghaebrahim AN, Budzik RF, Hicks WJ, Blasco J, Wu TY, Tsai JP, Schaafsma JD, Gandhi CD, Al-Mufti F, Sangha N, Warach S, Kleinig TJ, Yogendrakumar V, Ng F, Samaniego EA, Abdulrazzak MA, Parsons MW, Rahbar MH, Nguyen TN, Fifi JT, Mendes Pereira V, Lansberg MG, Albers GW, Furlan AJ, Jabbour P, Sitton CW, Sila C, Bambakidis N, Davis SM, Wechsler L, Hill MD, Grotta JC, Ribo M, Campbell BCV; SELECT2 Investigators. Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial. Lancet. 2024 Feb 24;403(10428):731-740. doi: 10.1016/S0140-6736(24)00050-3. Epub 2024 Feb 9.

Reference Type: DERIVED

PMID: 38346442 (View on PubMed)

Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Churilov L, Johns H, Sitton CW, Yogendrakumar V, Ng FC, Pujara DK, Blackburn S, Sundararajan S, Hu YC, Herial NA, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Al Shaibi F, Toth G, Abdulrazzak MA, Sharma G, Ray A, Sunshine J, Opaskar A, Duncan KR, Xiong W, Samaniego EA, Maali L, Lechtenberg CG, Renu A, Vora N, Nguyen T, Fifi JT, Tjoumakaris SI, Jabbour P, Tsivgoulis G, Pereira VM, Lansberg MG, DeGeorgia M, Sila CA, Bambakidis N, Hill MD, Davis SM, Wechsler L, Grotta JC, Ribo M, Albers GW, Campbell BC; SELECT2 Investigators. Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles. JAMA. 2024 Mar 5;331(9):750-763. doi: 10.1001/jama.2024.0572.

Reference Type: DERIVED

PMID: 38324414 (View on PubMed)

Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.

Reference Type: DERIVED

PMID: 36762865 (View on PubMed)

Sarraj A, Campbell BCV, Christensen S, Sitton CW, Khanpara S, Riascos RF, Pujara D, Shaker F, Sharma G, Lansberg MG, Albers GW; SELECT Investigators. Accuracy of CT Perfusion-Based Core Estimation of Follow-up Infarction: Effects of Time Since Last Known Well. Neurology. 2022 May 24;98(21):e2084-e2096. doi: 10.1212/WNL.0000000000200269. Epub 2022 Apr 21.

Reference Type: DERIVED

PMID: 35450966 (View on PubMed)

Sarraj A, Hassan AE, Abraham M, Ribo M, Blackburn S, Chen M, Hussain MS, Pereira VM, Ortega-Gutierrez S, Sitton C, Lavori PW, Cai C, Rahbar M, Pujara D, Shaker F, Lansberg MG, Campbell B, Grotta JC, Albers GW; SELECT2 Investigators. A randomized controlled trial to optimize patient's selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol. Int J Stroke. 2022 Jul;17(6):689-693. doi: 10.1177/17474930211035032. Epub 2021 Dec 15.

Reference Type: DERIVED

PMID: 34282987 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

G180275, Pro00056862

Identifier Type: -

Identifier Source: org_study_id