Academica Weekly: The Primary Record for the Week Ending 2 August 2026

Academica Weekly: The Primary Record for the Week Ending 2 August 2026

Trial registrations, clearances, recalls, guidance, safety reports, device listings, and insider filings — assembled from the primary sources with no editor in the loop.

The week of 27 July 2026 to 2 August 2026: 56 Phase 3 trial registrations; 102 Phase 2 trial registrations; 7 recall events; 100 510(k) clearances; 6 FDA guidance documents; 1,575 new Health Canada device licences; 2,644 ARTG device entries; 394 open-market insider purchases.

56 Phase 3 trial registrations
102 Phase 2 trial registrations
7 recall events
100 510(k) clearances
71Phase 1 registrations102Phase 2 registrations56Phase 3 registrations36Phase 4 registrations100510(k) clearances284PMA decisions7recall events6guidance documents352,949adverse event reports333,226device event reports27,811device listings2,644ARTG device entries1,575new device licences553label effective dates58,772new provider enumerations15,384,974industry payments95medtech patent grants96,474literature records394open-market insider purchases
One pill per source with new rows this week

Source Ledger

The latest event date each source holds, measured against its expected publication cadence. A stale source keeps its ledger line and loses its section.

SourceLatest eventState
ClinicalTrials.govPhase 1 · Phase 2 · Phase 3 · Phase 431 July 2026Current
FDA 510(k)17 July 202616 days behind
FDA PMA17 July 2026Current
FDA recalls29 July 2026Current
FDA guidance31 July 2026Current
FAERS30 June 2026Current
MAUDE30 June 2026Current
GUDID22 April 2026102 days behind
TGA ARTG1 August 2026Current
Health Canada31 July 2026Current
FDA drug labels31 July 2026Current
NPPES11 July 2026Current
Open Payments31 December 2024579 days behind
USPTO10 February 2026173 days behind
PubMed2 August 2026Current
SEC Form 431 July 2026Current

Phase 1 Trials

71 Phase 1 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHACullinan Therapeutics Inc.72
Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum DisorderKyushu University7
A Study of Eloralintide (LY3841136) in Participants With Obesity or OverweightEli Lilly and Company56
OLIG2 Inhibitor CT-179 for Recurrent and Newly-diagnosed GlioblastomaOlivia Newton-John Cancer Research Institute54
A Study of DS-3939a in Participants With Solid TumorsDaiichi Sankyo400
ATR 1072 in Participants With PRKAG2 SyndromeAtrium Therapeutics37
Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding StudyLiu Shu30
Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding StudyLiu Shu30
GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)Eddingpharm (Zhuhai) Co., Ltd.270
A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male VolunteersNanjing King-Friend Biochemical Pharmaceutical Co., Ltd.202

Phase 2 Trials

102 Phase 2 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)The Lymphoma Academic Research Organisation95
Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine CarcinomaWest China Hospital92
SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological MalignanciesPeking Union Medical College Hospital80
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHACullinan Therapeutics Inc.72
Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum DisorderKyushu University7
Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring TransfusionsHalia Therapeutics, Inc.50
Caffeine Consumption and Rate Control in Permanent Atrial FIBrillation: The CAFIB TrialHospital Universitario Getafe50
Retreat-Based Program for Violence-Exposed Women VeteransVA Office of Research and Development48
Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 AlterationsThe Lymphoma Academic Research Organisation44
A Study of DS-3939a in Participants With Solid TumorsDaiichi Sankyo400

Phase 3 Trials

56 Phase 3 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
Phase III Study of OT202 in Treating Moderate to Severe Dry EyeOcumension Therapeutics (Suzhou) Co., Ltd842
Modified DHAP Versus Standard DHAP in Relapsed/Refractory Diffused Large B-cell Lymphoma.King Edward Medical University74
Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With ObesityShahid Beheshti University of Medical Sciences60
Caffeine Consumption and Rate Control in Permanent Atrial FIBrillation: The CAFIB TrialHospital Universitario Getafe50
Comparison of Efficacy and Safety Profile Between Moisturizers Containing a Combination of 5% Hydro-Urea, Ceramide, With MultiVesicular Emulsion Technology and Petrolatum on Dry SkDr. dr. Lili Legiawati, SpKK(K)48
A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung CancerMediLink Therapeutics (Suzhou) Co., Ltd.442
Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral AnticoagulationNovartis Pharmaceuticals2,500
A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have DetectaPolish Myeloma Consortium248
A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With LocalSichuan Baili Pharmaceutical Co., Ltd.200
Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung CancerNational Taiwan University Hospital154

Phase 4 Trials

36 Phase 4 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)McMaster University966
Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar ExtractionCMH Lahore Medical College and Institute of Dentistry74
The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total ThyroidectomyUniversity Hospital Dubrava48
A Postmarketing Open-Label Study to Assess Residual Levonorgestrel (LNG) and Ethinyl Estradiol (EE) Content of TWIRLA® (Levonorgestrel and Ethinyl Estradiol) Transdermal SystemInsud Pharma28
A Study on the Preventive Effect of Electroacupuncture Combined With Dexmedetomidine in Post-stroke DepressionMin Su231
Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass SurgeryClinique Saint-Luc160
Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal SurgeryJeju National University School of Medicine138
Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal AnesthesiaSanliurfa Education and Research Hospital100
PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic ResponsesMassachusetts General Hospital100
Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission: A Randomized Double-Blind Placebo-Controlled TrialMahidol University90

510(k) Clearances

100 510(k) clearances this week; the 10 below lead the list.

K numberDeviceApplicantClassDecision
Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2
Zeiss Clinic 360Carl Zeiss Meditec, AG2
Drivewire 35 GuidewireRapid Medical Ltd.2
Cubresa BrainPETCubresa, Inc.2
SportSuite Vision SoftwareStryker Endoscopy
Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.2
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C CervicalStryker Spine2
Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.2
Natural CyclesNatural Cycles Nordic AB2
BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC2

PMA Approvals

284 PMA decisions this week; the 10 below lead the list.

PMADeviceApplicantDecision
Edwards Crimper: 9600CREdwards Lifesciences, LLC
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott Medical
Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29Edwards Lifesciences, LLC
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)Abbott Medical
HeartMate 3™ Left Ventricular Assist System (LVAS)Abbott Medical
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-PMedtronic, Inc.
AED 3; CPR Uni-PadzZOLL Medical Corporation
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, CobaltMedtronic Cardiac Rhythm Disease Management
Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD,Medtronic Cardiac Rhythm Disease Management
Vercise Deep Brain Stimulation (DBS) SystemsBoston Scientific Corp

Recalls

7 recall events this week.

FirmProductReasonCatalog rowsPosted
Instrumentation LaboratoryBrand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and aBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price c6
Stryker GmbHStryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.7
IsoTis OrthoBiologics, Inc.OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 71
ResMed Ltd.Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventDue to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.1
Windstone Medical Packaging, Inc.AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, PartWindstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injec8
Medtronic Perfusion SystemsEOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.6
Philips Medical SystemsBrilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 UpgradesThe clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, c3

FDA Guidance

6 guidance documents this week.

TitleTopicIssued
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent PartsBiosimilars; Drugs; Center for Drug Evaluation and Research; Draft
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Guidance for IndustryDrug Competition Action Plan, Generic Drugs; Drugs; Center for Drug Evaluation and Research; Final
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for IndustryDrug Competition Action Plan, Generic Drugs; Drugs; Center for Drug Evaluation and Research; Draft
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Guidance for Industry, IRBs, and Clinical InvestigatorsClinical Trials,; Biologics, Drugs; Office of the Commissioner; Final
Cancer Clinical Trial Eligibility Criteria: Performance Status: Guidance for Industry, IRBs, and Clinical InvestigatorsClinical Trials,; Biologics, Drugs; Office of the Commissioner; Final
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical InvestigatorsClinical Trials,; Biologics, Drugs; Office of the Commissioner; Final

Drug Safety Reports (FAERS)

352,949 adverse event reports this week; the 10 below lead the list.

ReactionReports
Off label use19,437
Drug ineffective17,826
Nausea13,583
Product dose omission issue12,230
Diarrhoea12,101
Death11,969
Fatigue11,899
Pruritus10,348
Headache9,032
Meningioma8,392

Device Safety Reports (MAUDE)

333,226 device event reports this week; the 10 below lead the list.

BrandManufacturerEvents
FreeStyle Libre 326,773
Dexcom G7 Continuous Glucose Monitoring System16,748
FreeStyle Libre 3 Plus13,218
t:slim X2 Insulin Pump with Control-IQ Technology10,423
DreamStation Auto CPAP8,072
CareLink SmartSync Common App iOS7,354
Inset Guard7,073
t:slim X2 Insulin Pump with Control-IQ+ Technology5,375
Quick Set4,518
MiniMed 780G US System BLE Connect 3.0 mg/dL4,366

Device Listings (GUDID)

27,811 device listings this week; the 10 below lead the list.

BrandCompanyGMDNPublished
MelpexMelpex Beauty InstrumentsGeneral-purpose surgical scissors, reusable
Anyplus Peek Cage SystemGS Medical Co., Ltd.Polymeric spinal interbody fusion cage
Wrap Around Quick ReleaseShielding International Inc.Radiation shielding apron
Anyplus Peek Cage SystemGS Medical Co., Ltd.Polymeric spinal interbody fusion cage
ProCureTwin Med, LLCWound hydrogel dressing, non-antimicrobial
TrellOss®-MCPNexxt Spine, LLCGeneral internal orthopaedic fixation system implantation kit
Golden Isles Pedicle Screw SystemIntelivation, LLCOrthopaedic implantation sleeve, reusable
TrellOss®-MCPNexxt Spine, LLCSpinal fixation plate, non-bioabsorbable
K2-HF SHOULDER, SH-6 T powder, 20g.Yeti Dentalprodukte GmbHDental appliance fabrication material, ceramic
Wrap Around Quick ReleaseShielding International Inc.Radiation shielding apron

Australia (TGA ARTG)

2,644 ARTG device entries this week; the 10 below lead the list.

BrandManufacturerSponsorClassEffective
Glaukos® iprism® SKatena Products IncRQSolutions Medical Devices Distribution SupportClass 1 Sterile
Glaukos® iprism® SKatena Products IncRQSolutions Medical Devices Distribution SupportClass 1 Sterile
KXL® SystemAvedro a Glaukos companyRQSolutions Medical Devices Distribution SupportClass IIa
Secureflex HF Surgical Gonio LensOcular Instruments IncRQSolutions Medical Devices Distribution SupportClass 1 Sterile
Boost Goggles™Avedro a Glaukos companyRQSolutions Medical Devices Distribution SupportClass 1
Glaukos® iprism® SXKatena Products IncRQSolutions Medical Devices Distribution SupportClass 1 Sterile
Benchmark Intracranial Access SystemPenumbra IncPenumbra Neuro Australia Pty LtdClass III
Benchmark Intracranial Access SystemPenumbra IncPenumbra Neuro Australia Pty LtdClass III
JustRight SurgicalHologic IncOptimed Technologies Pty LtdClass IIb
IV CATHETER for Single Use Pen TypeZhejiang Kindly Medical Devices Co Ltd.Syrinx Systems Pty LtdClass IIb

Canada (Health Canada MDALL)

1,575 new device licences this week; the 10 below lead the list.

DeviceCompanyClassLicensed
Supersoft Infant Nasal Cannula with Crush Resistant Tubing and Standard ConnectorMedline Industries, LP2
Set Zirkonzahn Multi Unit Abutment 17(Degree) L10 Type 2 for Zimmer Dental Tapered Screw-VentZirkonzahn SRL3
Set Narrow Ti-Base Non Hex for Astra Tech Implant System OsseospeedZirkonzahn SRL3
Set Narrow Ti-Base Non Hex for Astra Tech Implant System Ev/Uniabutment EvZirkonzahn SRL3
Set Narrow Ti-Base Non Hex for Anthogyr Axiom Reg / PxZirkonzahn SRL3
Set Narrow Ti-Base Hex for Zimmer Dental Tapered Screw-Vent 3.5Zirkonzahn SRL3
Set Narrow Ti-Base Hex for Zimmer Dental Spline Implant System 3.25Zirkonzahn SRL3
Set Narrow Ti-Base Hex for Zimmer Dental Eztetic Implant System NpZirkonzahn SRL3
Set Narrow Ti-Base Hex for Straumann Tissue Level (Standard Plus Narrow Neck Crossfit / Synocta) Nnc 3.5Zirkonzahn SRL3
Set Narrow Ti-Base Hex for Straumann Bone LevelZirkonzahn SRL3

Drug Labels

553 label effective dates this week; the 10 below lead the list.

BrandGenericManufacturerEffective
SugammadexSugammadexLupin Pharmaceuticals, Inc.
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMentholChattem, Inc.
Dehydrated AlcoholAlcoholAvenacy, LLC
ValsartanValsartanScieGen Pharmaceuticals, INC.
Clevariel Minoxidil Hair Growth SerumMinoxidilGuangzhou Ariel Medical Technology Co., Ltd.
FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.
Ustekinumab-aeknUstekinumab-AeknTeva Pharmaceuticals USA, Inc.
Rocuronium BromideRocuronium BromideShandong New Time Pharmaceutical Co., Ltd.
GabapentinGabapentinRemedyRepack Inc.
OzempicSemaglutideA-S Medication Solutions

Workforce (NPPES)

58,772 new provider enumerations this week; the 10 below lead the list.

StateNew providersOrganizations
CA7,9521,185
TX4,1741,146
FL3,9561,137
NY2,967489
MI2,564387
OH2,470418
IL1,973385
PA1,815295
MD1,805393
NC1,788433

Industry Payments (Open Payments)

15,384,974 industry payments this week; the 10 below lead the list.

PayerTotal (USD)Payments
BioNTech SE180,558,679164
AbbVie Inc.156,382,6831,720,745
Stryker Corporation132,155,940162,439
Medtronic, Inc.117,649,217342,148
Arthrex, Inc.104,199,46449,443
Edge Endo LLC91,139,12711
Zimmer Biomet Holdings, Inc.83,904,35132,760
Intuitive Surgical, Inc.72,225,869116,855
Takeda Pharmaceuticals U.S.A., Inc.71,616,187171,595
Advanced Accelerator Applications63,931,988167

Patents (USPTO, A61)

95 medtech patent grants this week; the 10 below lead the list.

AssigneeGrants
Globus Medical, Inc.8
Hytto Pte. Ltd.2
Medicrea International2
Koninklijke Philips N.V.2
Warsaw Orthopedic, Inc.2
Neodyne Biosciences, Inc.1
GlaxoSmithKline Intellectual Property Development Limited1
University of Florida Research Foundation, Incorporated1
Intuitive Surgical Operations, Inc.1
Universitätsspital Basel1

Literature (PubMed)

96,474 literature records this week; the 10 below lead the list.

PMIDTitleJournalRevised
Differential bone marrow aspirate DNA yields from commercial extraction kits.Leukemia
Imitation performance in toddlers with autism and those with other developmental disorders.Journal of child psychology and psychiatry, and allied disciplines
The mammalian phosphatidylinositol 3-phosphate 5-kinase (PIKfyve) regulates endosome-to-TGN retrograde transport.Journal of cell science
MAPK signaling contributes to rotaviral-induced cholangiocyte injury and viral replication.Surgery
The role of myeloperoxidase in the pathogenesis of postoperative adhesions.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
Human T cell epitopes of Mycobacterium tuberculosis are evolutionarily hyperconserved.Nature genetics
Differences in the association between sickness absence and long-term sub-optimal health by occupational position: a 14-year follow-up in the GAZEL cohort.Occupational and environmental medicine
Polymer folding: ABC of molecular origami.Nature chemistry
Longitudinal changes in Scores on the Autism Diagnostic Interview--Revised (ADI-R) in pre-school children with autism: Implications for diagnostic classification and symptom stability.Autism : the international journal of research and practice
Antipsychotic medication for early episode schizophrenia.The Cochrane database of systematic reviews

Literature by Subject (MeSH)

96,474 annotated literature records this week; the 10 below lead the list.

MeSH headingArticles
Humans 42,779
Female 24,089
Male 22,088
Middle Aged 13,073
Adult 13,034
Animals 9,730
Aged 9,647
Young Adult 4,881
Retrospective Studies 4,504
Adolescent 4,227

Insider Buying (Form 4)

394 open-market insider purchases this week; the 10 below lead the list.

TickerOwnerTradedSharesValue (USD)
Frangou Angeliki3,3932,538,367,767
NONEAbu Dhabi Investment Authority8,740,776125,000,087
N/ATPG GP A, LLC1,984,18250,000,000
Aghazadeh Behzad2,383,33336,115,495
NONEMSD Capital, L.P.1,274,19430,950,172
Huang Jack Jiajia1,495,98024,863,188
NONEAbu Dhabi Investment Authority932,91722,935,759
Huang Jack Jiajia1,264,32019,929,629
OrbiMed Advisors LLC1,000,00015,000,000
Gordon Carl L1,000,00015,000,000

Academica Weekly is assembled and published automatically each week. This issue covers 27 July 2026 to 2 August 2026 and was built on 3 August 2026.

Index

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