Advancingdialysis.org 2017 ASN Sponsored Symposium Presentation

1. AdvancingDialysis.org Addressing Unmet Needs in Dialysis Cardiovascular Care and Volume Control

2. AdvancingDialysis.org Disclosures Mike Kraus, MD, FACP Allan J. Collins, MD, FACP Peter McCullough, MD, MPH, FACC, FACP, FCCP, FAHA, FNKF Paul Komenda, MD, MHA, FRCPC Bill Davis Scientific Advisory Board Member: NxStage Medical, Inc. Unrestricted Educational Grants: NxStage Medical, Inc. Keryx Biopharmaceuticals, Inc. Satellite Healthcare Inc. Fresenius Medical Care Chief Medical Officer NxStage Medical Consulting Epidemiology: FibroGen Dialysis Providers: Executive Director Peer Kidney Care Initiative with 7 NPO and 6 FP CMO provider groups Scientific Advisory Board Member: NxStage Medical, Inc. Consulting Epidemiology: Fresenius Scientific Advisory Board Member: NxStage Medical, Inc., Boehringer Ingelheim, Otsuka, Alexion Paid Speaker: NxStage Medical, Inc.

3. AdvancingDialysis.org Important information All forms of hemodialysis, including treatments performed in-center and at home, involve some risks. In addition, there are certain risks unique to treatment in the home environment. Patients differ and not everyone will experience the reported benefits of more frequent hemodialysis. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping.

4. AdvancingDialysis.org Addressing a Case in Unmet Need Case in Unmet Need Discussion Lead: Michael Kraus, MD, FACP Indiana University School of Medicine 1. The DOPPS Practice Monitor. http://www.dopps.org/DPM/. Accessed May 20, 2015.

5. AdvancingDialysis.org Where it all begins • Mr. B.D. ‒ 52 yo bm ‒ APKD ‒ Prior PD, transplant times 13 years ‒ Transplant with acute failure due to Renal vein thrombosis, initiates thrice weekly HD (Texas) ‒ PD cavity is full of adhesions on laparoscopy ‒ Continues on in-center dialysis ‒ Transfers to your dialysis shift

6. AdvancingDialysis.org Hemodialysis • IHD 4 hours daily, 3x/week • Hypertension controlled on 3 drugs • Increased PO4 • Post dialysis fatigue • On transplant list – no partner Due to dialysis he abruptly “retired” Lives in Florida 6-months a year and wants to be more active Increased frequency home hemodialysis

7. AdvancingDialysis.org After training and going home • Afib • Echo – LVH (1.4 cm septum and PW thickness), Decreased LVEF 30%, diastolic dysfunction • Pulmonary Hypertension • Minimal diffuse valvular changes • Cardiac Catheterization with normal coronary anatomy

8. AdvancingDialysis.org Cardiovascular Clinical Considerations Discussion Lead: Peter McCullough, MD, MPH, FACC, FACP, FCCP, FAHA, FNKF Baylor University Medical Center 2. Kotanko P, Garg AX, Depner T, et al. Effects of frequent hemodialysis on blood pressure: Results from the randomized frequent hemodialysis network trials. Hemodial Int. 2015;19(3):386-401. doi:10.1111/hdi.12255.

9. AdvancingDialysis.org Outline • Blood pressure • Left ventricular hypertrophy • Myocardial stunning • Clinical outcomes

11. AdvancingDialysis.org AUDIENCE POLL: Which choice discloses the three major mechanisms of left ventricular failure? 1) Pressure overload, volume overload, and cardiomyopathy 2) Atrial fibrillation, reduced ejection fraction, mitral regurgitation 3) Excess salt intake, hypertension, and myocardial infarction 4) Viral infarction, alcohol intake, and B-vitamin deficiency 5) Erythropoietin toxicity, left ventricular hypertrophy, and tachycardia 10

12. AdvancingDialysis.org Effective Fluid Management Associated with Better Cardiovascular Outcomes VOLUME OVERLOADPRESSURE OVERLOADINTRADIALYTIC MYOCARDIAL STUNNING CARDIOVASCULAR RELATED DEATH CARDIOMYOPATHY

13. AdvancingDialysis.org AUDIENCE POLL: The pre-hemodialysis systolic blood pressure range with the lowest hazard ratio for mortality is: 1) 90-120 mm Hg 2) 120-140 mm Hg 3) 130-160 mm Hg 4) 160-180 mm Hg 5) >180 mm Hg 10

14. AdvancingDialysis.org 1-year Cumulative Systolic Blood Pressure and Mortality1 1.Carmine Zoccali et al. Chronic Fluid Overload and Mortality in ESRD. JASN 2017;28:2491-2497. doi: 10.1681/ASN.2016121341

15. AdvancingDialysis.org AUDIENCE POLL: After 12 months of home hemodialysis, what percent of patients will require no antihypertensive therapy? 1) <1% 2) 5% 3) 17% 4) 34% 5) 42% 10

16. AdvancingDialysis.org Antihypertensive Medications Needed in Home HD Patients Statistically Significant Decline in Utilization Nair S. et al. New European evidence with Home HD Patients: 12 months follow-up in KIHDNEy cohort. Presented at 54th ERA-EDTA conference 2017, Madrid. Mean Agents/day % using No Rx % using ≥2 Rx Baseline 1.51 27% 42% Month 6 1.12 36% 34% Month 12 0.91 42% 25% p for trend <0.001 <0.001 <0.001

18. AdvancingDialysis.org Clinical Consequences of Increased Left Ventricular Mass Thickening of the LV wall (left ventricular hypertrophy) can stimulate a vicious cycle • Lead to more LVH progression • Complicated by ESRD uremic risk factors • Lead to heart failure • Lead to arrhythmias and sudden death

19. AdvancingDialysis.org AUDIENCE POLL: With home hemodialysis there is a reduction in left ventricular hypertrophy. With each 10-gram reduction in LV mass, what is the associated reduction in mortality? 1) 8% 2) 18% 3) 28% 4) 38% 5) 48% 10

20. AdvancingDialysis.org More Frequent Hemodialysis Regression of Left Ventricular Hypertrophy 1. McCullough PA, Chan CT, Weinhandl ED, Burkart JM, Bakris GL. Intensive Hemodialysis, Left Ventricular Hypertrophy, and Cardiovascular Disease. American Journal of Kidney Diseases, Volume 68, Issue 5, S5 - S14. …each 10-point decrement in percentage change in left ventricular mass was associated with 28% lower risk for cardiovascular death…1

22. AdvancingDialysis.org High Ultrafiltration Rates Correlated to Intradialytic Hypotension 15.4 13.5 3.4 0.6 0 2 4 6 8 10 12 14 16 18 Center 3x/wk Center 5x/wk Home 5x/wk Home Nocturnal -41.7 -18.5 -1.5 17.1 -50 -40 -30 -20 -10 0 10 20 30 Center 3x/wk Center 5x/wk Home 5x/wk Home Nocturnal 1.Jefferies et.al. Frequent hemodialysis schedules are associated with reduced levels of dialysis-induced cardiac injury (Myocardial stunning). Clin J Am Soc Neprhol 2011 June, 6(6); 1326-1332. Higher Ultrafiltration Rates Greater Drops in Blood Pressures

23. AdvancingDialysis.org Regional Wall Motion Abnormalities Shown to Increase Mortality Risk1 15.4 13.5 3.4 0.6 0 2 4 6 8 10 12 14 16 18 Center 3x/wk Center 5x/wk Home 5x/wk Home Nocturnal 4.8 4.6 3.3 3.0 0 1 2 3 4 5 6 Center 3x/wk Center 5x/wk Home 5x/wk Home Nocturnal 1.Burton, JO et al., Hemodialysis-Induced Cardiac Injury: Determinants and Associated Outcomes. Clin J Am Soc Nephrol 4: 914–920, 2009. 2.Jefferies et.al. Frequent hemodialysis schedules are associated with reduced levels of dialysis-induced cardiac injury (Myocardial stunning). Clin J Am Soc Neprhol 2011 June, 6(6); 1326-1332. Higher Ultrafiltration Rates More Wall Motion Abnormalities2

24. AdvancingDialysis.org AUDIENCE POLL: Regional wall motion abnormalities of the left ventricle over the course of dialysis are associated with all of the above except: 1) Use of cinacalcet 2) Intradialytic hypotension 3) High ultrafiltration rate 4) Three times per week dialysis 5) Higher mortality 10

25. AdvancingDialysis.org AGGRESSIVE ULTRAFILTRATION RATES HYPOVOLEMIA INTRADIALYTIC HYPOTENSION REGIONAL WALL MOTION ABNORMALITIES CARDIAC HYPO- PERFUSION 2/3 of conventional hemodialysis patients suffer from recurrent HD-induced ischemic injury1 MYOCARDIAL STUNNING 1.Jefferies et.al. Frequent hemodialysis schedules are associated with reduced levels of dialysis-induced cardiac injury (Myocardial stunning). Clin J Am Soc Neprhol 2011 June, 6(6); 1326-1332. Graphical summary source: Flythe JE, Brunelli SM: The risks of high ultrafiltration rate in chronic hemodialysis: implications for patient care. Semin Dial 24(3):259-265, 2011

27. AdvancingDialysis.org Over 41% of all deaths were cardiovascular-related, with nearly identical percentages in hemodialysis and peritoneal dialysis patients.1 CHAPTER 1, FIGURE 2: Distribution of primary cause of death in hemodialysis patients, 2011 to 2013.2 1.Saran R, Li Y, Robinson B, et al. US Renal Data System 2014 Annual Data Report: Epidemiology of Kidney Disease in the United States. 2.Am J Kidney Dis Off J Natl Kidney Found. 2015;66(1 Suppl 1):Svii, S1-305. doi:10.1053/j.ajkd.2015.05.001 Cardiovascular-related Deaths in Prevalent Dialysis Patients are Common

28. AdvancingDialysis.org The FHN Trial Group. In-Center Hemodialysis Six Times per Week versus Three Times per Week. The New England Journal of Medicine. 010:363;2287-2300. Frequent Hemodialysis Associated with 12-month Improvements in Several Cardiovascular Markers1 Likely due to improved control of extracellular volume excess. Left ventricular mass Adjusted mean reduction of 16.4±2.9 g versus 2.6±3.2 (P<0.001) 12% REDUCTION FHN RANDOMIZED CLINICAL TRIAL FINDINGS: Hypotensive episodes 10.9% vs. 13.6% of monitored sessions with at least one episode, (P=0.04) 20% FEWER Systolic blood pressure Adjusted mean SPB decrease 9.7±18.2 mm Hg versus 0.9±16.2 mm Hg (P<0.001) 7% DECREASE Antihypertensive agents Change from baseline agents decreased 0.87±1.85 versus −0.23±1.35 (P< .001) 32% LESS

29. AdvancingDialysis.org Daily home hemodialysis patients had 20%-25% fewer CV hospital days per patient- year than in-center HD patients: ↓ 25% lower risk for cerebrovascular disease ↓ 41% lower risk for heart failure, ﬂuid overload, and cardiomyopathy ↓ 16% lower risk for hypertensive disease McCullough PA, Chan CT, Weinhandl ED, Burkart JM, Bakris GL. Intensive Hemodialysis, Left Ventricular Hypertrophy, and Cardiovascular Disease. American Journal of Kidney Diseases, Volume 68, Issue 5, S5 - S14. Cardiovascular Benefit of Home Dialysis

30. AdvancingDialysis.org 58% 5-year survival +8,000 HHD Patients More Frequent HHD* 50% 5-year survival +45,000 PD Patients Peritoneal Dialysis 40% 5-year survival +420,000 Conventional HD Patients In-center HD More frequent HHD is associated with better 5-year relative survival 5-year patient survival after initiating treatment U.S. Renal Data System, USRDS 2015 Annual Data Report: Table 6.3. Adjusted survival (%) by (a) treatment modality and incident cohort year (year of ESRD onset), and (b) age, sex, race, and primary cause of ESRD, for ESRD patients in the 2008 incident cohort (initiating ESRD treatment in 2008) Abbreviation: ESRD, end- stage renal disease. *Data source: NxStage patient data on file

31. AdvancingDialysis.org Addressing Unmet Needs in Cardiorenal Care Chronic Fluid Overload and Mortality in ESRD FO = Fluid Overload Determined by Bioimpedence 1.Carmine Zoccali et al. Chronic Fluid Overload and Mortality in ESRD. JASN 2017;28:2491-2497. doi: 10.1681/ASN.2016121341

32. AdvancingDialysis.org Therapy Prescription: More Frequent Home Hemodialysis Discussion Lead: Allan Collins, MD, FACP University of Minnesota School of Medicine Chief Medical Officer, NxStage Medical, Inc. Zoccali C et al. Chronic fluid overload and mortality in ESRD. J Am Soc Nephrol. 2017. (in press)

33. AdvancingDialysis.org AUDIENCE POLL: How do you think of therapy prescription for more frequent home hemodialysis? 1) Solute removal to achieve target KT/V 2) Fluid control 3) Patient tolerance to the therapy 4) PO4 control 5) All the above 10

34. AdvancingDialysis.org AUDIENCE POLL: More frequent HD is targeted at which areas of unmet need? 1) Fluid overload 2) Uncontrolled BP 3) LVH/Heart Failure 4) Patient tolerance to the therapy 5) All the above 10

35. AdvancingDialysis.org Pathophysiology and Outcomes Challenges with Thrice-Weekly Hemodialysis 1.Rocco MV, Burkart JM. Prevalence of missed treatments and early sign-offs in hemodialysis patients. J Am Soc Nephrol. 1993 Nov;4(5):1178-83. Fluid Overload Uncontrolled Hypertension Left Ventricular Hypertrophy Heart Failure Hospitalizations and Death “Early Sign- Offs” and “No-Shows” 1 High Ultrafiltration Rate Intradialytic Hypotension Cramping, Dizziness, Nausea, etc. Long Post- Dialysis Recovery Time Poor QOL Intervention: Lower Ultrafiltration Rate, but Maintain Session Length

36. AdvancingDialysis.org AUDIENCE POLL: What should be the fluid removal rate target? 1) UFR <13 ml/kg/hr 2) UFR <10 ml/kg/hr 3) UFR <7 ml/kg/hr 4) Unclear which is best 10

37. AdvancingDialysis.org Dialysis Recovery Time is Associated with All-cause Mortality Kaplan- Meier Unadjusted Chazot et al; Blood Purification 2017; 44:89-97 All-cause Mortality <6.8 ml/kg/hr ≥6.8 ml/kg/hr

38. AdvancingDialysis.org Dialysis therapy prescription General Concepts: Two Part Approach (Consistent with John Agar Hemodialysis International Editorial, 2015)  Set Fluid removal per week ‒ Set desired dry weight ‒ Limit UFR to reduce cardiac/organ system stunning ‒ Limit UFR <10ml/kg/hr for safety and tolerability (reduce recovery time)  NxStage mean UFR 6-7 ml/kg/hr short daily; 2-3 ml/kg/hr Nocturnal  Standardized weekly KT/V: normalized volumes cleared of Urea ‒ 2.1 per week of continuous removal (minimum) from Guidelines ‒ Mainly addresses the dietary intake for a week ‒ Provides basic removal of K, adds HCO3, and removes protein uremic toxins  Large molecules and PO4 take greater time for removal because of large spaces and slow transport (30+ hours per week)

39. AdvancingDialysis.org Fluid Removal Rates and Control of Volume is a Core Unmet Need • The range of fluid removal rates has been a subject of discussion (<7ml/kg/hr, <10ml/kg/hr, <13 ml/kg/hr) • UFR appears to relate to how patients feel, hypotensive episodes, recovery time and associated mortality (lower the rate the better) • Tolerability of fluid removal is the key element when trying to achieve a desired target weight to control HTN and treat heart failure • Lowering UFR on conventional three times per week HD is very challenging to implement in a fixed schedule

40. AdvancingDialysis.org How should treatment time and frequency be determined? 1) Whatever we can get the patient to do 2) UF time per week is based on tolerable UFR and total volume to be removed 3) Set the number of treatment per week to fit minimum UF time per week 4) All the above AUDIENCE POLL: 10

41. AdvancingDialysis.org Therapy Rx Principles: Weekly CALCULATE RESULT PRESCRIBEINPUT UF TIME / WEEK KG gain / Week 1500 mL/day x7 10.5 liters/week QUF limit <10 mL/kg/h < 700 mL/h ♂ < 500 mL/h ♀ 15 Total Hours / Week Sessions / Week Hours / Session

42. AdvancingDialysis.org High Saturation Dialysate: Dialysate + UF = Volume Cleared • The high saturation of dialysate means for each liter of dialysate used it equals a liter cleared of solutes ‒ Urea ‒ Creatinine ‒ PO4 • Ultrafiltration adds convective clearance removing solutes at the same concentration as in the blood • The single pool volumes cleared each treatment is essentially the volume of dialysate plus the UF divided by the patient TOTAL Body Water

43. AdvancingDialysis.org How do low flow systems deliver enough solute clearance vs. conventional HD? 1) High dialysate saturation maximizes solute removal similar to PD 2) Total time per week and frequency are used to deliver the weekly total dose 3) PO4 removal is also improved based on greater dialysate saturation at lower Qd 4) All the above AUDIENCE POLL: 10

44. AdvancingDialysis.org Weekly Total Normalized Water Cleared of Urea (KxT) Based on continuous STD weekly Kt/V I II III IV V eGFRStageContinuous Clearance 15 eGFR (ml/min) 30 60 90 STD L/wk Urea 80-90 L/wk 80-90 L/wk 128 L/wk 342 L/wk 605 L/wk 1000 L/wk HD x 3 HD x 6 nocturnal Transplant PD x 7 HD x 5 Normal

45. AdvancingDialysis.org Prescribing Hemodialysis Therapy Urine side clearance (dialysate side) D/P ratio like PET

46. AdvancingDialysis.org Dialyzer Urea Clearance Dialysate Flow (Qd) and Blood Flow Rate (Qb) When dialysate flow is below 200 ml/min this determines the basic clearance

47. AdvancingDialysis.org 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00 0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800 Urea Qb -400 mL/min Dialysate/PlasmaRatio(D/P) Dialysate Flow Rate (Qd) NxStage System Conventional Hemodialysis D/P Ratio for Urea* NxStage Polyether Sulfone Dialyzer *Urea KoA in vivo 851 ml/min *Ken Leypoldt kinetics ASN 2017

48. AdvancingDialysis.org Comparison of Dialysate Saturation NxStage – Lower Qd Conventional – Higher Qd NxStage Conventional HD BFR 300 ml/min Qd 200 • Urea Saturation: 85% • PO4 Saturation: 64% BFR 300 ml/min Qd 500 • Urea Saturation: 40% • PO4 Saturation: 31% BFR 400 ml/min; Qd 200 • Urea Saturation: 93% • PO4 Saturation: 69% BFR 400 ml/min; Qd 500 • Urea Saturation: 57% • PO4 Saturation: 35%

49. AdvancingDialysis.org High Saturation Dialysate: Dialysate + UF = Volume Cleared (KxT) • The high saturation of dialysate means for each liter of dialysate used it equals a liter cleared of solutes ‒ Urea ‒ Creatinine ‒ PO4 • Ultrafiltration adds convective clearance removing solutes at the same concentration as in the blood • The single pool volumes cleared each treatment is essentially the volume of dialysate plus the UF divided by the patient TOTAL Body Water

50. AdvancingDialysis.org Leypoldt and Collins Dosing Protocol ASN Abstract/Poster - Based on V: Dialysate Volume rounded* *Tabulated values are dialysis volumes in L per treatment (obtained by dividing Kt by 0.85) predicted to achieve a weekly stdKt/V of 2.1 rounded up to the nearest 5 L. Dialysate Volume needed to nearest 5 liters

51. AdvancingDialysis.org In Sum  Therapy Rx can be addressed in two parts ‒ Volume to be removed per week by addressing UFR ‒ Solute removal based on Normalized Volumes of Total Body Water cleared per week and per treatment  UF volume per week is divided by tolerable UFR to obtain hours needed per week  STD Weekly KT/V provides the target normalized volumes per week to be cleared overall ‒ spKT/V is used to determine normalized volume cleared per treatment ‒ Dialysate needed per treatment is computed based on saturation of the dialysate rounded up to the nearest 5 liters  The dosing calculator will give alternatives for various schedules

52. AdvancingDialysis.org Conclusions • Therapy prescription for any dialysis is targeted at Volume to be removed and solute to be cleared • Volume removal is the first step to address control of CVD areas and tolerability of therapy • All dialysis modalities use solute clearance as the basis of therapy Rx: Blood Side or Dialysate Side • Conventional HD is based on Blood side clearance • PD and HHD is based on dialysate clearance • More frequent HD can deliver comparable, if not superior, therapy compared to conventional HD

53. AdvancingDialysis.org Framing Home Hemodialysis Options Discussion Lead: Paul Komenda, MD, MHA, FRCPC Seven Oaks General Hospital 3. Assimon MM et al. Ultrafiltration Rate and Mortality in Maintenance Hemodialysis Patients. Am J Kidney Dis. Volume 68, Issue 6, December 2016, Pages 911-922.

54. AdvancingDialysis.org 60% LIFESTYLE 30% CLINICAL 10% ADMINISTRATIVE Home Hemodialysis Considerations

55. AdvancingDialysis.org 1972 Medicare establishes ESRD Program 1983 Medicare “Composite Rate for HD” CAPD By 1970, 40% of Hemodialysis performed at home 1962-1972 Dialysis Death Panels Emerging therapy options 1943 First working dialyzer 1960 Scribner Shunt 1950 1980 199019701960 CCPD 2000

56. Percentage of Home Dialysis Therapy Utilization Worldwide Vol 2, ESRD, Figure 11.15 Distribution of the percentage of prevalent dialysis patients using in-center HD, home HD, or peritoneal dialysis (CAPD/APD/IPD), 2015

57. AdvancingDialysis.org  Improved LVM  Better BP  Lower PO4 N=245 (2010) Randomized Control Trials JAMA, September 19, 2007—Vol 298, No. 11  Improved LVM  Better BP  Lower PO4 N=52 (2007) ? Improved LVM (p=0.09)  Better BP  Lower PO4 N=82 (2011)

58. AdvancingDialysis.org “Sunk Costs” Komenda P et al. An economic assessment model for in-center, conventional home, and more frequent home hemodialysis. Kidney International. Volume 81, Issue 3, Pages 307-313 (February 2012). DOI: 10.1038/ki.2011.338 • If Intensive Home Hemodialysis unlikely to last more than 12-24 months, not a cost effective option • Not taking into consideration PATIENT time for training.

59. AdvancingDialysis.org Conventional Machine Limitations Portability Renovations Water Quality User Interface

60. AdvancingDialysis.org The Cycler and Cartridge Simple interface using shapes, colors, and diagrams to aid in operation of system Color coded cartridge clamps to match fluid pathways

61. AdvancingDialysis.org Increased Frequency Home Hemodialysis Results 4. Rayner HC, Zepel L, Fuller DS, et al. Recovery time, quality of life, and mortality in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2014;64(1):86-94.

62. AdvancingDialysis.org Significantly reduced post-dialysis recovery time Study of Medicare patients starting more frequent home hemodialysis with NxStage System One Key Findings: • 87% improvement in time to recovery and significant improvement in quality of life measures 1Jaber BL, Lee Y, Collins AJ, et al. Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010;56(3):531-539.

63. AdvancingDialysis.org Purported Benefits Clinical • Blood Pressure • Volume Control • LVH Regression • Ca/PO4 balance Lifestyle • QOL Metrics • Flexibility Economic • Lower Operating Costs • Cost Utility

64. AdvancingDialysis.org

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66. AdvancingDialysis.org Increased Frequency Home Hemodialysis Results Discussion Leads: Michael Kraus, MD, FACP Indiana University School of Medicine Bill Davis Current Home Hemodialysis Patient

67. AdvancingDialysis.org B.D. • BP normal and no meds • Activity increased • Serial Echo with improved LVEF (60%) No wma or Valvular disease • No recurrence A Fib His story

68. AdvancingDialysis.org www.AdvancingDialysis.org

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