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Alport syndrome (AS) Market outlook Epidemiology Market Forecast and Competitive Landscape Report 2018 To 2030 Sample Re

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Alport syndrome (AS) Market outlook Epidemiology Market Forecast and Competitive Landscape Report 2018 To 2030 Sample Re

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  1. 2019 Valued Knowledge Partners Valued Knowledge Partners Alport syndrome (AS) - Market outlook, Epidemiology, Market Forecast and Competitive Landscape Report - 2020 To 2030 - Sample Report  Disease overview (Classification, Severity & Stages, Risk fac- tors, Coexisting conditions, pathogenesis, treatment land- scape)  Emerging therapies (Pipeline assessment and key clinical trials profile)  Epidemiology (Incidence, prevalence, mortality and survival)  Market share and patient share uptake  KOL’s perspective on current treatment & unmet needs  Market and product event analysis  Market forecast 2020- 2030 (10 years of future market projections) Market outlook & Insight Report

  2. Report overview Report Summary Thelansis “Alport (AS) - Market outlook, Epidemi- ology, Market Forecast and Competitive Landscape - 2020 To 2030 ” this report provides a comprehensive study of the disease area landscape and changing market dynamics with respect to the current & future market events for the 8 MM countries (USA, EU5, Japan & China)  Key market outlook  11 Year Forecast  08Major Markets  Epidemiology (incidence, prevalence, diagnosed & treatment eligible patient pool)  Therapies (LoT’s & patient share)  Therapy area landscape (approved and emerging)  Pipeline Assessment  Future competition Analysis Syndrome  The report provides a comprehensive view of Alport syndrome dis- ease events, classification, severity level, stages, identified and emerg- ing biomarkers, progression, manifestations, symptoms, risk factors, pathogenesis, genetic basis and treatment guidelines at country level  Alport Syndrome Comprehensive insight on patient segmentation based on Age, Sex, classification (X-linked, Autosomal, and Digenic ), stages (Stage - 0, I, II, III, IV), Renal Manifestation Frequency (hematuria, proteinuria, end-stage renal disease, transplantation), Extra-renal Manifestation (sensorineural hearing loss, Ocular Lesions and others), Inheritance & Mutation (XLAS; COL4A5, ARAS;COL4A3, & COL4A4, ADAS; COL4A3 OR COL4A4) has been provided into the epidemiology (Incidence and Prevalence) section of the Alport Syn- drome (AS) and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and Chi- na  Drug utilization and analysis on the current clinical practice, KOL per- spective on upcoming therapies, estimated TPP for pipeline assets, clinical characteristics upcoming therapies and future treatment para- digm  Market aggregation on newly diagnosed patient pool, Thelansis esti- mation on persistence, compliance, adherence and a historic view of changing market dynamics and product-level patient flow of AS in the 8 MM Countries for the period 2020 - 2030  Current clinical Practices  Future treatment paradigm  Product attribute analysis  A comprehensive record of both the present and rising disease bur- den with respect to the treatments for AS are provided, along with impact of the new treatments and the probable patent expiry consid- ering the current market dynamics. A detailed review of 8MM cur- rent and forecasted market including the drug outreach at different country level based on their order of entry  Unmet Needs  Market Attractiveness  Emerging Drug Profiles  Market Drivers and Barriers News Update Online support Update 1Qtr Free Forecast model

  3. Report Highlights 1 Table of content 04 2 Click on the page number to view the details MS Excel Based Forecast Model 14 3 Market outlook 15 4 Disease Overview & Epidemiology 16 5 Market Scenario & Competitive Landscape 17 6 18 KoLs & Payer’s Perspective 7 Market Forecast & Pricing Scenario 19 8 Data collection approach (Primary & Secondary research) 20 Note: The table of content is just for ease of users/ reviewer to access different section of the sample page, however the complete table of content has been placed separately in the sample report News Update Forecast model Update 1Qtr Free Online support

  4. Table of content 1.Alport Syndrome –Key Findings Summary 1.1.Clinical findings 1.1.1.Disease overview 1.1.2.Therapeutic practices 1.1.3.Future outlook 1.2.Alport Syndrome Commercial findings 1.2.1.Alport Syndrome market scenario 2020 1.2.2.Alport Syndrome market scenario 2025 1.2.3.Alport Syndrome market scenario 2030 2.Alport Syndrome Overview 2.1.Disease Introduction 2.2.Pathophysiology 2.3.Signs and Symptoms 2.4.Risk Factors 2.5.Etiology 2.6.Classification 2.7.Pathogenesis 2.8.Diagnosis 2.9.Complications 2.10.Treatment Algorithm 2.10.1.Treatment in US (guidelines) 2.10.2.Treatment in EU-5 (guidelines) 2.10.3.Treatment in Japan (guidelines) 2.10.4.Treatment in China (guidelines) 2.11.Treatment Goals for Alport Syndrome 2.12.Referral Patterns 2.12.1.Referral Scenario in US 2.12.2.Referral Scenario in EU-5 2.12.3.Referral Scenario in Japan 2.12.4.Referral Scenario in China 2.13.Alport Syndrome Prognosis 2.14.Healthcare burden 2.14.1.Healthcare burden in US News Update Forecast model Update 1Qtr Free Online support

  5. Table of content 2.14.2.Healthcare burden in EU-5 2.14.3.Healthcare burden in Japan 2.14.4.Healthcare burden in China 2.15. Unmet Needs in Alport Syndrome management 2.16. Market Opportunity for Alport Syndrome 2.17.KOL Comments on current and upcoming/expected treatment practices in Alport Syn- drome 3.Epidemiology 3.1.Epidemiology Overview 3.2.Alport Syndrome Epidemiology by Geography 3.2.1. Alport Syndrome Epidemiology in US (2015-2030) 3.2.1.1.Incidence of Alport Syndrome 3.2.1.2.Diagnosed cases 3.2.1.3.Treatable Patient Pool 3.2.1.4.Epidemiology Trends 3.2.2. Alport Syndrome Epidemiology in EU-5 (2015-2030) 3.2.2.1.Incidence of Alport Syndrome 3.2.2.2.Diagnosed cases 3.2.2.3.Treatable Patient Pool 3.2.2.4.Epidemiology Trends 3.2.3. Alport Syndrome Epidemiology in Japan (2015-2030) 3.2.3.1.Incidence of Alport Syndrome 3.2.3.2.Diagnosed cases 3.2.3.3.Treatable Patient Pool 3.2.3.4.Epidemiology Trends 3.2.4. Alport Syndrome Epidemiology in China (2015-2030) 3.2.4.1.Incidence of Alport Syndrome 3.2.4.2.Diagnosed cases 3.2.4.3.Treatable Patient Pool 3.2.4.4.Epidemiology Trends 3.3.Epidemiology Trends (World-wide) 4.Alport Syndrome Market Outlook 4.1.US Alport Syndrome Market Forecast 2020-2030 4.1.1.Market Progression (Futuristic) News Update Forecast model Update 1Qtr Free Online support

  6. Table of content 4.1.2.Market Trends and Expectations 4.1.2.1.Worst case scenario 4.1.2.2.Base Case Scenario 4.1.2.3.Best Case Scenario 4.1.3.Drivers and Barriers 4.2.UK Alport Syndrome Market Forecast 2020-2030 4.2.1.Market Progression (Futuristic) 4.2.2.Market Trends and Expectations 4.2.2.1.Worst case scenario 4.2.2.2.Base Case Scenario 4.2.2.3.Best Case Scenario 4.2.3.Drivers and Barriers 4.3.France Alport Syndrome Market Forecast 2020-2030 4.3.1.Market Progression (Futuristic) 4.3.2.Market Trends and Expectations 4.3.2.1.Worst case scenario 4.3.2.2.Base Case Scenario 4.3.2.3.Best Case Scenario 4.3.3.Drivers and Barriers 4.4.Germany Alport Syndrome Market Forecast 2020-2030 4.4.1.Market Progression (Futuristic) 4.4.2.Market Trends and Expectations 4.4.2.1.Worst case scenario 4.4.2.2.Base Case Scenario 4.4.2.3.Best Case Scenario 4.4.3.Drivers and Barriers 4.5.Italy Alport Syndrome Market Forecast 2020-2030 4.5.1.Market Progression (Futuristic) 4.5.2.Market Trends and Expectations 4.5.2.1.Worst case scenario 4.5.2.2.Base Case Scenario 4.5.2.3.Best Case Scenario 4.5.3.Drivers and Barriers News Update Forecast model Update 1Qtr Free Online support

  7. Table of content 4.6.Spain Alport Syndrome Market Forecast 2020-2030 4.6.1.Market Progression (Futuristic) 4.6.2.Market Trends and Expectations 4.6.2.1.Worst case scenario 4.6.2.2.Base Case Scenario 4.6.2.3.Best Case Scenario 4.6.3.Drivers and Barriers 4.7.Japan Alport Syndrome Market Forecast 2020-2030 4.7.1.Market Progression (Futuristic) 4.7.2.Market Trends and Expectations 4.7.2.1.Worst case scenario 4.7.2.2.Base Case Scenario 4.7.2.3.Best Case Scenario 4.7.3.Drivers and Barriers 4.8.China Alport Syndrome Market Forecast 2020-2030 4.8.1.Market Progression (Futuristic) 4.8.2.Market Trends and Expectations 4.8.2.1.Worst case scenario 4.8.2.2.Base Case Scenario 4.8.2.3.Best Case Scenario 4.8.3.Drivers and Barriers 4.9.Key Expected Milestones (world-wide) Impacting the Market 5.Alport Syndrome Competitive Landscape 5.1.Pipeline Therapies Overview 5.1.1.Phase II/IIII Therapies 5.1.1.1.Bardoxolone Methyl (Reata Pharmaceuticals) Profile 5.1.1.1.1.Current Status 5.1.1.1.2.Trial details, results 5.1.1.1.3.Approval Timeline 5.1.1.1.4.Likelihood of approval 5.1.1.1.5.Expected Product Positioning 5.1.1.1.6.Revenue Projections (Till 2030) 5.1.1.2.Attribute Analysis against rest of the pipeline News Update Forecast model Update 1Qtr Free Online support

  8. Table of content 5.1.2. Phase II Therapies 5.1.2.1.RG-012 (Sanofi) Profile 5.1.2.1.1.Current Status 5.1.2.1.2.Trial details, results 5.1.2.1.3.Approval Timelines 5.1.2.1.4.Likelihood of approval 5.1.2.1.5.Expected Product Positioning 5.1.2.1.6.Revenue Projections (Till 2030) 5.1.2.2.All other clinical therapies 5.1.3.List of active Pre-clinical Therapies 5.1.3.1.BMP-7 (Ember Therapeutics) 5.1.3.1.1.Status in Alport Syndrome 5.1.3.1.2.Company positioning 5.1.3.2.VAR 300 (ZyVersa Therapeutics, Inc.) 5.1.3.2.1.Status in Alport Syndrome 5.1.3.2.2.Company positioning 5.1.3.3.All other pre-clinical therapies 5.1.4.List of Inactive/discontinued assets 5.1.4.1.Business impact of discontinuations on current pipeline 5.1.5.Potential winners/Blockbusters from Alport Syndrome Pipeline 6.Regulatory/Approval Scenario 6.1.Regulatory/Approval Framework in US 6.1.1.Policy Framework 6.1.2.Payer Expectations 6.2.Regulatory/Approval Framework in UK 6.2.1.Policy Framework 6.2.2.Payer Expectations 6.3.Regulatory/Approval Framework in France 6.3.1.Policy Framework 6.3.2.Payer Expectations 6.4.Regulatory/Approval Framework in Germany 6.4.1.Policy Framework 6.4.2.Payer Expectations News Update Forecast model Update 1Qtr Free Online support

  9. Table of content 6.5.Regulatory/Approval Framework in Italy 6.5.1.Policy Framework 6.5.2.Payer Expectations 6.6.Regulatory/Approval Framework in Spain 6.6.1.Policy Framework 6.6.2.Payer Expectations 6.7.Regulatory/Approval Framework in Japan 6.7.1.Policy Framework 6.7.2.Payer Expectations 6.8.Regulatory/Approval Framework in China 6.8.1.Policy Framework 6.8.2.Payer Expectations 7.Clinical Trial Assessment –Current and Future Paradigm 7.1.Distribution of Primary Endpoints across trials 7.2.Distribution of Secondary Endpoints across trials 7.3.Evolution and acceptance of surrogate endpoints 7.4.Key Investigator initiated trials 7.5.Attrition analysis 7.5.1.Suspended/Discontinued Assets 7.5.2.Failed Trials, Reasons and Business Impact 7.5.3.Terminated Trials, Reasons and Business Impact 7.5.4.Withdrawn Trials, Reasons and Business Impact 7.6.Trial enrollment scenario and challenges 7.7.Clinical Trial Guidance (across geographies) 8.Thelansis Commentary 8.1.Key Unmet needs in Alport Syndrome 8.2.Possible Best-case Clinical Trial Strategies 8.3.Possible Best Case Targeted Product Profile (TPP) 8.4.Possible Best-case Market positioning strategies 8.5.Possible Best-case Market Access Strategies 8.6.Possible Best-case LCM Strategies 8.7.Overall View on Alport Syndrome Market in Dollar Value 9.Report Methodology News Update Forecast model Update 1Qtr Free Online support

  10. Table of content 9.1.Secondary research 9.2.Primary research 9.3.Data collation 9.4.Insight Generation 10.About Thelansis 10.1. Our Capabilities 10.2. Our Services 10.3. Our Contacts 10.4. Disclaimer News Update Forecast model Update 1Qtr Free Online support

  11. Market Forecasting Model - Snapshot Patient based forecast model 2020 - 2030 (Snapshot - 1.1) Patient based forecast model 2020 - 2030 (Snapshot - 1.2) News Update Forecast model Update 1Qtr Free Online support

  12. Sample Diagrams Market outlook Report Summary Current 8 MM Mar- ket Incident Patients Prevalence patients Diagnosed Patients Treated Patients Marketed Drugs Phase II/ III/ PR drugs 2020Market Size 2025 Market Size 2030 Market Size $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM $XX MM XX US $XX MM US US XX UK $XX MM UK UK 2020 - 2030 Market size by region/ country; and growth XX DE $XX MM DE DE XX FR $XX MM FR FR XX IT $XX MM IT IT XX SP $XX MM SP SP Filed XX JP $XX MM JP JP Key events XX CH $XX MM CH T o t a l CH 2020 - 2030 - Market share by re- gion/ country; and growth $XXX MM $XXX MM Key players XX Total $XXX MM Total Leading Drugs (2025 Market) Leading Drugs (2020 Market) Leading Drugs (2025 Market) Sales Sales Sales $XX MM $XX MM Drug A Drug C $XX MM Drug C $XX MM 2020 - 2030 Market revenue by coun- try/ region Drug B Drug D $XX MM Drug D $XX MM Current Attain- ment High/Low High/Low Year to peak Impact treatment paradigm Oppor- tunity Prime Unmet Needs Peak Year Sales $XX MM $XX MM High/Low High/Low Patent expiry Promising Emerging Therapies Launch Year Drug A Drug B XXXX XXXX 2020 - 2030 market/ epidemiology Country specific scenario Probabil- ity Key Events (2020-2030) Impact on Market Probability High/ Moderate/ Low High/ Moder- ate/Low +/- Source: Thelansis Knowledge partner; Executive summary 2020 - 2030 Patients by country / region News Update Online support Update 1Qtr Free Forecast model

  13. Sample Diagrams Epidemiology Disease overview:  Alport syndrome is an inherited progressive form of glomerular dis- ease that is often associated with sensorineural hearing loss and ocular defects. The primary abnormality arises from mutations in genes encoding the type IV collagen protein family. This syndrome is a genetically heterogeneous disease having different mutations and forms of inheritance: X-linked (mutations in COL4A5 gene), au- tosomal recessive (homozygous or compound heterozygous muta- tions in COL4A3 or COL4A4 genes) and autosomal dominant (heterozygous mutations in COL4A3 or COL4A4 genes). 2020 - 2030 Potential patient tower  X-linked AS (XLAS) caused by COL4A5 mutations is the most com- mon form, accounting ~80% of AS, however 15 percent of cas- es,showed mutations in both theCOL4A3orCOL4A4gene and is inherited in anautosomal recessivepattern. Number of patients on supportive and off-label therapies Epidemiology Research:  The total number of Alport syndrome increased from 128,924 in 2020 to 182,305 by 2030. The USA comprises of ~38 of the total diagnosed cases of AS followed by China, EU5 and Japan. ~80% cas- es had typical glomerular basement membrane (GBM) changes of AS, ~10% patients initially had pathology features of diffuse thin- ning of the GBM only, 14% patients showed pathology of focal seg- mental glomerulosclerosis (FSGS). Treated patients forecast by region/ country 2020 - 2030  Around ~64% cases shown mutations in COL4A3 and ~32% of cases shown COL4A4. 46% patients had no missense mutation, hoever, ~51% to 39~ patients had one or two missense mutations. Diagnosed incidence Vs. Treated  According to Thelansis, the diagnosed population of Alport syn- drome will significantly increase at a CAGR of X% during the period 2020-2030 in 8 MM markets  Over the course of 11 years till 2030, Thelansis expects the number of prevalent cases to increase at the CAGR of X.XX% in the US. The prevalence may reach X,XXX patients by 2030 in the US. In the EU-5 market(s), the prevalence is expected to reach X,XXX patients by 2030 whereas in Japan the rate of CAGR is relatively less with X.XX%. It is expected that in Japan, the prevalence pool will reach X,XXX in 2030 Key patient segmentation Market Trends: Key Takeaways News Update Online support Update 1Qtr Free Forecast model Illustrative sample

  14. Sample Diagrams Competitive landscape Alport Syndrome Market Scenario:  Current clinical practice recommendations for delaying endstage renal disease in patients with Alport syndrome focus on early in- troduction of RAAS inhibitors to suppress urinary protein excre- tion Key targets mutations  Angiotensin-converting enzyme (ACE) inhibition lengthens surviv- al in the patients with autosomal recessive Alport syndrome and X-linked Alport syndrome  chronic kidney failure progresses to end-stage kidney disease, re- quiringdialysisor transplantation.Kidney transplantationin peo- ple with Alport syndrome is usually successful, but some studies have reported that about 10% of transplanted patients develop inflammation of the kidneys Key assets on different phases of development Competitive Landscape:  Considering Alport syndrome is an excellent model of CKD with proteinuria and fibrosis, orphan drug designation with premium pricing benefits , number of patients to be treated will be sub- stantial and finally s no approved treatment several drug candi- dates are in Phase II and II/ III stages of development by various companies. Key assets among these are, Bardoxolone Methyl; Reata Pharmaceuticals, RG-012; Sanofi/ Regulus/ Genzyme, BMP- 7; Ember Therapeutics, VAR300; ZyVersa Therapeutics. The launch of key assets will positively impact the overall market dur- ing 2020 to 2030 in 8 MM countries. Key players in the AS space, with assets under development  While there is a lot of competitive activity going on in pipeline for AS, companies like Reata Pharmaceuticals; Bardoxolone Methyl holds Orphan drug designation by US FDA and EMA. Emerging patient share and uptake; 2020 - 20130  Patients treated with bardoxolone experienced a significant in- crease in eGFR of 7.8 mL/min/1.73 m2(n=18; p=0.003) at Week 12 compared to baseline and to be found significantly improves kidney functions and well tolerated among the different cohort of treatments Unmet needs News Update Online support Update 1Qtr Free Forecast model

  15. Sample Diagrams Real-world evidences KOL Opinion: based on Primary Market Research (PMR)  “…..No approved therapies, identification of novel biomarkers for clinical use, and progress in understanding the underlying patho- physiology, there are remains a major unmet medical need ….. ….” (Department of Nephrology, Columbia University Medical Center , USA) Key stakeholder insight  “…..a …. biomarker mutation has……….. systems in the scientific literature…..identification of optimal patient care strategies and interpretation of data are complicated.....…..” (Academic & Re- searcher, Division Urology & Nephrology, Stanford University School of Medicine, USA) Market access: Role of HTA bodies in European region  “…..among current therapy for AS, abnormal GBM for approxi- mately 50% …... unmet medical need...prioritized if sufficient sci- entific…...to date there is no pharmacological therapy has been licensed to…....…..” (Department of molecular biology, University of Michigan, USA) Alport Syndrome Payer’s perspective:  From the payer’s perspective majorly focused on wide range of treatment options rather than raising concern on cost savings. In coming years the treatment of Alport syndrome could change dramatically as US FDA and EMA has labeled orphan designation some of the key products. The payer’s and reimbursement agen- cies more concern about strong clinical outcomes data which have great evidence on managing the symptomatic conditions including quality of life, however cost could go up to 135,000 USD to 272,000 USD per year Key therapies & cost burden  The European nations regulatory bodies and payers are having a very conservative mind-set with respect to the approval and ac- cess of non potential assets, which will rise the country level dis- ease burden as well as the treatment cost in coming years. Apart from cost, payers have also concern on the quality of life parame- ters (e.g., therapies or diagnostic tests) that have not demonstrat- ed improvements in the outcomes that matter to patients Regulatory framework & guidelines Health economics & outcome News Update Online support Update 1Qtr Free Forecast model

  16. Sample Diagrams Market forecasting Alport Syndrome Market Forecast:  Thelansis’ research team expects the Alport syndrome market potential for 2030 at $X.XXB in 8MM countries. Out of this mar- ket, 68.5% sales are expected to be contributed from the US mar- ket whereas XX.X% is expected to come from EU-5. Japan and Chi- na are expected to contribute XX.X% and X.X% respectively. Future market - 2020 To 2030  Alport syndrome current market stands at $XXXX.XM which is ex- pected to grow from 2019 to 2024 at a CAGR of X.X%. Majorly this is expected because of expected approvals of pharmacotherapies in the space. The market is expected to grow exponentially post 2024 at a CAGR of XX.X% (for the period 2024-2030). The most substantial increase in the market will be witnessed by the US market. Country-wise revenue estimation  Major Milestone of market growth is the entry of Orphan desig- nated products like reducing oxidative stress, and inhibiting pro- inflammatory signaling, which will command a premium pricing and can offer long term cost burden reduction for the patients. However, targeted therapies do carry a high attrition rate across the orphan indication space and this can be a key catalyst in de- termining market value for 2030. Patient share and market uptake Alport Syndrome Pricing Scenario:  Upcoming therapy probably transform the treatment paradigm of Alport syndrome in the near future. Clinical trials shows the reso- lution of inflammation by restoring mitochondrial function, reduc- ing oxidative stress, and inhibiting pro-inflammatory signaling . Of course, some questions about targeted therapy still remain un- solved.  Thelansis expects upcoming therapies may raise significant con- cerns with respect to the treatment cost as much as 135,000 USD to 272,000 USD per patient . Disease burden matrix  To control the cost research have developed algorithm for tiered testing guide to enhance the clinical diagnosis of AS, in the other hand it is hard to distinguish genetic variations such as pin- pointing the phenotype and exact biomarker. Market Access News Update Online support Update 1Qtr Free Forecast model

  17. Methodology Primary Market Research (PMR) Secondary research News Update Update 1Qtr Free Online support Forecast model

  18. Contact Us About Thelansis: - As the name depicts Thelansis is specialized in “Therapy Area Landscape Analy- sis” along with market intelligence and consultancy that supports pharmaceutical, biotechnology, and diagnostics companies to successfully prepare, launch, and commercialize their products. Our Syndicated research reports include Market Insight, Pipeline Insight, Product Insight, Specialized Re- ports, Indication Outlook and Market Access Reports. Our focused therapeutic approach provides our clients with clinical and disease area expertise from an integrated team of academic, medical, and industry specialists of our panel, Ask for our report offerings, and Indication specific sample pages by sharing your email ID with us at, p.potdar@thelansis.com Peeyush Potdar Delivery Head Email: p.potdar@thelansis.com www.thelansis.com Delivery office Delivery office Sales office Sales office B-1030, C Wing Vrindavan tech village Marathahalli Outer ring road Bangalore- 560037 183-Asylum Street Hartfort, CT-06103, USA Email Email Telephone Telephone clientsupport@thelansis.com sales@thelansis.com USA +1-302-380-3552 India +91-9899921259 News Update Update 1Qtr Free Online support Forecast model

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