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Wu-Wong J.R.,Vidasym, Inc. | Kawai M.,Vidasym, Inc. | Chen Y.-W.,Vidasym, Inc. | Nakane M.,Vidasym, Inc.
British Journal of Pharmacology | Year: 2011

BACKGROUND AND PURPOSE Vitamin D receptor (VDR) modulators (VDRMs) such as calcitriol, paricalcitol and doxercalciferol are commonly used to manage hyperparathyroidism secondary to chronic kidney disease (CKD). CKD patients experience extremely high risks of cardiovascular morbidity and mortality. Clinical observations show that VDRM therapy may be associated with cardio-renal protective and survival benefits for CKD patients. However, hypercalcaemia remains a serious side effect for current VDRMs, which leads to the need for frequent dose titration and serum Ca (calcium) monitoring. Significant clinical benefits can be derived from a VDRM with cardiovascular protective effects without the hypercalcaemic liability. EXPERIMENTAL APPROACH Male Sprague-Dawley rats were 5/6 nephrectomized and 6 weeks later, after they had established uraemia, elevated parathyroid hormone levels, endothelial dysfunction and left ventricular hypertrophy, the rats were treated with VS-105, a novel VDRM. The effects of VS-105 were also tested in cultured HL-60 cells. KEY RESULTS VS-105 induced HL-60 cell differentiation with an EC 50 value at 11.8 nM. Treatment (i.p., 3× a week over a period of 2 weeks) of the 5/6 nephrectomized rats by VS-105 (0.004-0.64 μg·kg -1) effectively suppressed serum parathyroid hormone without raising serum Ca or phosphate levels. Furthermore, 2 weeks of treatment with VS-105 improved endothelium-dependent aortic relaxation and attenuated left ventricular abnormalities in a dose range that did not affect serum Ca levels. Similar results were obtained when VS-105 was administered i.p. or by oral gavage. CONCLUSIONS AND IMPLICATIONS VS-105 exhibits an overall therapeutic product profile that supports expanded use in CKD to realize the cardiovascular protective effects of VDR activation. © 2011 Vidasym. British Journal of Pharmacology © 2011 The British Pharmacological Society.


Patent
Vidasym, Inc. | Date: 2010-04-12

Disclosed is a compound of Formula (I)


Compositions comprising metal ions or clusters such as ferrous and/or ferric iron compounds or magnesium, zinc, lanthanum and other metal ion compounds and fiber components such as gum Arabic in a complex, methods for preparing such compositions of matter, and the use thereof for treatment of adsorbing certain accessible targets in the gastrointestinal tract and in an extracorporeal system, are provided herein.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 299.22K | Year: 2013

DESCRIPTION (provided by applicant): Inflammatory bowel diseases (IBD) involve chronic inflammation of all or part of the digestive tract. Symptoms may include abdominal pain, severe diarrhea and malnutrition. IBD primarily includes ulcerative colitis (UC)and Crohn's disease (CD). In the West, the prevalence has increased in the past 50 years to 120-200/100,000 persons for UC and 50-200/100,000 persons for CD. Incidence rates for both UC and CD are highest among individuals who are 20-30 years old. Thus, IBD affects individuals in the most healthy and productive years of life, resulting in long-term cost to the patient, health-care syste and society. Current drugs for treating UC and CD have not shown consistent effects, especially for chronic maintenance therapy. New agents are needed to treat UC and CD and prevent relapse. Vitamin D receptor (VDR), once activated by its endogenous hormone calcitriol (1,25(OH) 2D3), modulates signaling pathways in the inflammation pathway. Pre-clinical and clinical studieshave also shown that the vitamin D-VDR axis plays an important role in regulating many inflammatory factors involved in IBD. Despite encouraging data on VDRM's benefits for the cardiovascular, CNS, immune, and renal systems, currently VDRMs are mainly indicated for managing secondary hyperparathyroidism in chronic kidney disease, and to a lesser degree used to treat osteoporosis and psoriasis. One of the reasons for this is due to the narrow therapeutic window of current VDRMs in the 1-4-fold range as determined by comparing doses required for efficacy vs. the hypercalcemic toxicity. Consequently, current on-market VDRMs require frequent dose titration and serum calcium monitoring, which causes considerable challenges in clinical management. An ideal VDRM should be with little or no hypercalcemic toxicity in the efficacious dose range. Vidasym has taken a unique drug discovery/development approach to discover novel VDRMs that are highly differentiated from existing VDRMs. Vidasym's VS-110 has a therapeutic window of gt50-fold with no detectable hypercalcemic toxicity in the efficacious dose range. We hypothesize that VS-110 has potent therapeutic efficacy for the treatment of IBD. Specific Aim 1: To assess the therapeutic efficacy of VS-110 in blocking the development of colitis using experimental colitis models. Specific Aim 2: To elucidate the anti-colitic mechanism underlying the therapeutic effects of VS-110. Once this phase I study is completed, the data will allow the advancement of VS-110 into Phase II IND-enabling studies including VS-110 synthesis scale-up, process development and pharmacokinetics, metabolism, safety and toxicology. The completion of Phase II studies will allow VS-110 to enter human clinical trials. Vidasym plans to develop VS-110 intoan oral, once daily capsule (0.2 - 5 g/day) for treating IBD. Currently drugs for anti-inflammatory diseases in the GI tract such as mesalamine (Asacol, Lialda, Pentasa) and budesonide achieved US 2.9 billion in annual worldwide sales in 2011. Assuming VS- 110 has a 20% penetration into the IBD market, the estimated annual sales will be ~US 0.58 billion. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Vidasym's phase I STTR study will investigate the feasibility of using VS-110, Vidasym's novelvitamin D receptor modulator, to treat inflammatory bowel diseases (IBD). Up to 600,000 individuals in the US have IBD, and incidence rates are highest among individuals who are 20-30 years old. Thus, IBD affects individuals in the most healthy and productive years of life, resulting in long-term cost to the patient, health-care system and society. Current drugs for IBD have not shown consistent effects. There is an urgent medical need for the development of an effective and novel resuscitation approach for the treatment of IBD. VS-110, once developed to treat IBD, will help patients regain control of their health and lives. Even a modest 20% reduction in the number of patients with IBD would bring a minimum of 1+ billion annual savings in medical costs inthe US.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 278.58K | Year: 2013

DESCRIPTION (provided by applicant): Osteoporosis is a major public health threat. National Osteoporosis Foundation estimated that the US national direct expenditures for osteoporotic hip fractures were at 17 billion in 2005 and it would increase to 25billion in 2025. Current treatments for osteoporosis include several anti-resorptive (or anti-catabolic) and some anabolic agents. VDRMs such as calcitriol are currently used to treat osteoporosis in several ex-US countries. VDRMs influence bone metabolismthrough regulation of intestinal calcium absorption, parathyroid hormone, receptor activator of nuclear factor-kB ligand, and also via direct effects on osteoblasts and osteoclasts. Despite encouraging data on VDRM's benefits for treating osteoporosis, VDRMs are not used in osteoporosis patients in the US likely due to the fact that those currently on the market have substantial hypercalcemic toxicity that interferes with calcium homeostasis. All VDRMs on the market for osteoporosis are hypercalcemic, andrequire frequent serum calcium monitoring and dose titration. An ideal VDRM should be with little or no hypercalcemic toxicity in the efficacious dose range. Since VDRMs are well known to have anabolic effects on the bone, a VDRM without hypercalcemic toxicity for the treatment of osteoporosis will provide significant benefits to patients receiving the standard of care. Vidasym has taken a unique approach to discover and develop novel VDRMs. Data from extensive animal studies show that VS-105 has an exceptionally wide therapeutic index (TI) at gt50-fold (comparing efficacy vs. side effect). We hypothesize that VS-105 will exhibit better efficacy than calcitriol in stimulating anabolic bone formation and also in increasing bone mineral density (BMD) with lesshypercalcemic side effects. The specific aims of this Phase I study are: (1) To compare the effects between VS-105 and calcitriol on BMD and bone parameters in ovariectomized female rats. (2) To compare the effects between VS-105 and calcitriol on bone resorption and formation in mouse calvariae bone primary organ culture. Once this phase I study is completed, the data will allow the advancement of VS-105 into Phase II IND-enabling studies including VS-105 synthesis scale-up, process development and pharmacokinetics, metabolism, safety and toxicology. The completion of Phase II studies will allow VS-105 to enter human clinical trials. Vidasym plans to develop VS-105 into a reimbursable prescription drug to treat osteoporosis in patients receiving the standard of care. Based on the information provided by EvaluatePharma, osteoporosis medications achieved US 13+ billion in annual worldwide sales in 2011. This number is likely to increase based on the projections of increased patient numbers. The approach of developing VS-105 for osteoporosis, once introduced into the market, will decrease the incidence of vertebral fractures by at least 25 % (based on information from current on-the-market VDRMs for osteoporosis), which shall translate into ~ 4 billion in annual health care savings in the US. Assuming Vidasym's VS-105 has a modest 5% penetration into the osteoporosis market, the estimated annual sales will be US 0.6+ billion. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Vidasym's phase I SBIR study will investigate the feasibility of using VS-105, a novel vitamin D receptor modulator (VDRM), to treat osteoporosis. National Osteoporosis Foundation estimated that the US national direct expenditures for osteoporotic hip fractures were at 17 billionin 2005 and it would increase to 25 billion in 2025. Current treatments for osteoporosis have serious side effects and low compliance issues. VDRMs such as calcitriol are currently used to treat osteoporosis in several countries outside the US. VDRMs arenot used in the US to treat osteoporosis likely due to their hypercalcemic toxicity. Limitation of current therapy demonstrate that a new treatment approach such as VS-105 that is efficacious with minimal toxicity offers a significant opportunity for improved outcomes with substantial societal benefit.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.48M | Year: 2016

DESCRIPTION provided by applicant Osteoporosis is a major public health threat The American Association of Orthopaedic Surgeons estimates that the cost of treating patients with a low energy fracture in was US$ billion and projected costs for care of osteoporosis and low energy fractures over the next two decades are $ billion Current treatments for osteoporosis include several anti resorptive or anti catabolic and some anabolic agents VDRMs such as calcitriol are currently used to treat osteoporosis in several ex US countries VDRMs influence bone metabolism through regulation of intestinal calcium absorption parathyroid hormone receptor activator of nuclear factor kB ligand and also via direct effects on osteoblasts and osteoclasts Despite encouraging data on VDRMandapos s benefits for treating osteoporosis VDRMs are not used in osteoporosis patients in the US likely due to the fact that those currently on the market have substantial hypercalcemic toxicity that interferes with calcium homeostasis Consequently VDRM therapy requires frequent serum calcium monitoring and dose titration An ideal VDRM should be with little or no hypercalcemic toxicity in the efficacious dose range Since VDRMs are well known to have anabolic effects on the bone a VDRM without hypercalcemic toxicity for the treatment of osteoporosis will provide significant benefits to patients receiving the standard of care Vidasym has taken a unique approach to discover and develop novel VDRMs such as VS Data from extensive animal studies show that VS has an exceptionally wide therapeutic index TI at andgt fold vs TI of calcitriol at fold Results from SBIR Phase I confirm that VS exhibits potent anabolic effects on the bone in a dose range that does not affect serum calcium The mechanism of action studies demonstrate that while VS is potent in stimulating osteoblast activities osteoclast activitie are reduced leading to an increase in bone growth bone mineral density and bone volume These positive data strongly support the advancement of VS into Phase II SBIR The specific aims of this Phase II study are To complete synthesis and formulation of VS under Good Manufacturing Practice GMP in preparation for a Phase I clinical study To file an IND with the FDA for the indication of osteoporosis in preparation for a Phase I clinical study with VS Vidasym plans to develop VS into a reimbursable prescription drug to treat osteoporosis in patients receiving the standard of care According to a report from GBI Research the osteoporosis therapeutics market in was at $ billion and is forecasted to grow at a CAGR of to $ billion in An independent report by EvaluatePharma stated that osteoporosis medications achieved US$ billion in annual worldwide sales in and this number is likely to increase based on the projections of increased patient numbers Assuming Vidasymandapos s VS has a modest penetration into the osteoporosis market when launched in the estimated annual sales will be US$ billion PUBLIC HEALTH RELEVANCE Data from SBIR Phase I confirm that VS exhibits potent anabolic effects on the bone in a dose range that does not have side effects These positive data strongly support the advancement of VS into the next development phase which consists of manufacturing GMP compliant VS and filing an IND with the FDA in preparation for a Phase I clinical study The cost of treating patients with a low energy fracture in was US$ billion and projected costs for care of osteoporosis over the next two decades are $ billion Current treatments for osteoporosis have serious side effects and low compliance issues A new treatment approach such as VS that is efficacious with minimal toxicity offers a significant opportunity for improved outcomes with substantial societal benefit


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 219.12K | Year: 2011

DESCRIPTION (provided by applicant): Twenty-six million people in America have chronic kidney disease (CKD). Anemia, cardiovascular diseases, secondary hyperparathyroidism, renal osteodystrophy and other complications are common in CKD. Current treatmentsincluding ACE inhibitors for CKD patients mainly focus on managing symptoms and disease complications. Despite the various treatments available, the five-year survival rate is ~33% and the mortality risk increases with kidney disease progression and secondary hyperparathyroidism. Vitamin D receptor modulators (VDRMs) have been shown to reduce proteinuria/albuminuria in CKD patients and also provide survival benefits for CKD patients. Despite encouraging data on VDRM's potential renal and survival benefits for the CKD patients, currently in the CKD field VDRM is only indicated for managing secondary hyperparathyroidism (with elevated PTH). Hypercalcemic toxicity that interferes with calcium homeostasis and detriments body functions is the limiting factor to expanded use of on-market VDRMs. Therefore, a novel VDRM which retains the efficacy without the toxicity shared by current VDRMs would have significant clinical benefit. An ideal VDRM should be with little or no hypercalcemic toxicity in the efficacious dose range that could reduce PTH and slow kidney disease progression. Vidasym has taken a unique drug discovery/development approach to discover novel VDRMs that are highly differentiated from existing VDRMs. Vidasym's Vida-5 has no detectable hypercalcemic toxicity in the dose range that suppresses PTH to the normal level (vs. other VDRMs with overlapping dose ranges for efficacy and toxicity). With Vida-5's superior safety and efficacy profiles established, the next step is to determine the feasibility of using Vida-5 to treat kidney disease progression and also its long-term side effect potential in animal studies. The specific aims of this Phase I study are: (1) to conduct an animal study to show the synergistic effect of Vida-5 and an ACE inhibitor on reducing biomarkers (such as serum creatinine and proteinuira) indicative of kidney disease progression; (2) to conduct a toxicity animal study to prepare Vida-5 for Phase II studies. Once this phase I study is completed the data will allow the advancement ofVida-5 into Phase II IND-enabling studies including Vida-5 synthesis scale-up, process development and pharmacokinetics, metabolism, safety and toxicology. The completion of Phase II studies will allow Vida-5 to enter human clinical trials. Vidasym plans to develop Vida-5 into a reimbursable prescription new drug to treat kidney disease progression. Once developed, such a drug will not only reduce the mortality rate of CKD, but also reduce the need for dialysis. Current VDRMs for secondary hyperparathyroidism alone achieve US 1+ billion in annual sales in 2009. Zemplar and Hectorol dominate the US dialysis market (gt80%) due to their slightly less hypercalcemic toxic profile (~2-4 fold less toxic than generic Calcijex, the endogenous hormone calcitriol,). Anovel VDRM such as Vida-5 for treating kidney disease progression could easily achieve an annual US sales at 1+ billion. PUBLIC HEALTH RELEVANCE: Vidasym's phase I SBIR study will determine the feasibility of using Vida-5 to treat chronic kidney disease (CKD) progression. Globally gt 350 million individuals have CKD and this number is projected to increase to gt550 million by 2025. Although various modalities and substances are available for CKD, the mortality rate for CKD patients remains high (~33%) and the number of dialysis CKD patients keeps increasing. There is an urgent medical need for the development of an effective and novel resuscitation approach for the treatment of CKD. Limitations of current therapy demonstrate that a new treatment approach such as Vida-5 to reduce the need for dialysis and also reduce the mortality rate of CKD offers a significant opportunity for improved outcomes with substantial societal benefit.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 159.65K | Year: 2012

DESCRIPTION (provided by applicant): Twenty-six million people in America have chronic kidney disease (CKD). Diabetes is by far the leading cause of CKD (diabetic nephropathy), accounting for 44% of new cases of dialysis (in 2005). Current treatments including ACE inhibitors for CKD patients mainly focus on managing symptoms and disease complications. Despite the various treatments available, the five-year survival rate is ~33% and the mortality risk increases with kidney disease progression and secondary hyperparathyroidism. Vitamin D receptor modulators (VDRMs) have been shown to reduce proteinuria/albuminuria in diabetic nephropathy patients and also provide cardiovascular and survival benefits for CKD patients. Despite encouraging data on VDRM's potential renal, cardiovascular and survival benefits for the CKD patients, currently in the CKD field VDRM is only indicated for secondary hyperparathyroidism (with elevated PTH). Hypercalcemic toxicity that interferes with calcium homeostasis and detriments bodyfunctions is the limiting factor to expanded use of on-market VDRMs. A novel VDRM which retains the efficacy without the toxicity shared by current VDRMs would have significant clinical benefit. An ideal VDRM should be with no hypercalcemic toxicity in the efficacious dose range that could reduce PTH and provide cardiovascular benefits. Vidasym has taken a unique approach to discover novel VDRMs that are highly differentiated from existing VDRMs. In the clinically validated 5/6 nephrectomized uremic rat model Vidasym's VS-105 has no detectable hypercalcemic toxicity in the dose range that improves cardiovascular function and suppresses PTH to the normal level (vs. other VDRMs with overlapping dose ranges for efficacy and toxicity). Vidasym plans to developVS-105 into a reimbursable prescription new drug to treat CKD patients. Initial focus for VS-105 in clinical studies is on diabetic nephropathy in CKD patients. Thus, a logical step is to determine the efficacy of VS-105 in diabetic nephropathy animal models. The specific aims of this Phase I study are: (1) To compare the therapeutic efficacy between VS-105 and paricalcitol (the VDRM that currently has the largest US market share) in blocking the progression of diabetic nephropathy in experimental models oftype 1 and type 2 diabetes. (2) To elucidate the mechanism underlying the renoprotective effect of VS-105. Data from this phase I study will allow the advancement of VS-105 into Phase II IND-enabling studies including VS-105 synthesis scale-up, process development and pharmacokinetics, metabolism, safety and toxicology. The completion of Phase II studies will allow VS-105 to enter human clinical trials. Current VDRMs for secondary hyperparathyroidism alone achieve US 1+ billion in annual sales in 2010. Zemplar (paricalcitol) and Hectorol dominate the US dialysis market (gt80%) due to their slightly less hypercalcemic toxic profile (~2 to 4 fold less toxic than generic Calcijex, the endogenous hormone calcitriol). A novel VDRM such as VS-105 for treating CKD could potentially achieve annual US sales at 1+ billion. PUBLIC HEALTH RELEVANCE: Vidasym's phase I STTR study will investigate the feasibility of using VS-105 to treat chronic kidney disease (CKD) related to diabetes (diabetic nephropathy). Diabetes is the leading causes of CKD. According to National Kidney Foundation, ~30% of patients with Type 1 (juvenile onset) diabetes and up to 40% of those with Type 2 (adult onset) diabetes eventually will suffer from kidney failure. In 2010 39.6% of people with diagnosed and 41.7% with undiagnosed diabetes had CKD. Globally gt 350 million individuals have CKD and this number is projected to increase to gt550 million by 2025 largely due to the growing epidemic of metabolic syndrome and diabetes. Although various modalities and substances are available for CKD, the number of diabetic CKD patients keeps increasing and the mortality rate for CKD patients remains high (~33%). There is an urgent medical need for the development of an effective and novel resuscitation approach for the treatment of diabetic nephropathy. Limitations of current therapy demonstrate that a new treatment approach such as VS-105 to reduce the need for dialysis and also reduce the mortality rate of CKD offers a significant opportunity forimproved outcomes with substantial societal benefit.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 217.35K | Year: 2012

DESCRIPTION (provided by applicant): Twenty-six million people in America have chronic kidney disease (CKD). Despite the various treatments available to CKD patients, the five-year survival rate is ~33%. Inadequately controlled serum phosphate levels in CKD can lead to various pathologies of clinical importance such as further deterioration of kidney function, cardiovascular complications, renal osteodystrophy, and increased mortality. Current oral phosphate binders on the market have serious shortcomings:(1) suboptimal and inefficient phosphate binding, (2) high pill burden (large number of pills per day), unpalatable and hence low compliance, (3) expensive, especially for the calcium-free phosphate binders, and (4) side effects and safety concerns such ashypercalcemia, aluminum toxication, negative influence on other medication, gastrointestinal (GI) side effects and accumulation in organs. Vidasym has taken a unique approach to discover VS-501, a natural polymer derived from plants that is chemically processed to become highly effective in absorbing phosphate and other minerals in the GI tract without systemic toxicology effects. To confirm VS-501's superior safety and efficacy profiles, an important step is to conduct a head-to-head comparison between VS-501 and sevelamer (the preferred phosphate binder currently on the market) in the clinically validated 5/6 nephrectomized (NX) uremic rat model. Thus, the specific aims of this Phase I study are: (1) to compare the therapeutic efficacy between VS-501 andsevelamer carbonate in the 5/6 NX uremic rats. Acceptance criteria: VS-501 will exhibit better efficacy with less side effects than sevelamer carbonate; (2) to elucidate the renal and cardiovascular benefits of phosphate control in CKD. Acceptance criteria: VS-501 will show better heart and kidney protective effects than sevelamer. Achieving these aims will confirm the superior profile of VS-501 as a clinical candidate to treat hyperphosphatemia in CKD and also demonstrate the efficacy of phosphate controlon ameliorating disease progression and cardiovascular complications in CKD, which shall lead to the Phase II IND-enabling studies (safety and toxicology) for VS-501. The completion of Phase II studies will allow VS-501 to enter human clinical trials. Vidasym plans to develop VS-501 into a reimbursable prescription new drug to treat CKD. Once developed, such a drug will not only reduce the mortality rate in CKD, but also reduce the need for dialysis. Current phosphate binders achieve US 1+ billion in annualworldwide sales mainly in dialysis patients. Sevelamer alone showed US 750 million in annual worldwide sales. Estimating from the sales numbers, gt90% of dialysis patients receive phosphate binders, but lt 1% Stage 3/4 CKD patients in US are treated. Assuming VS-501 has a modest 3% penetration into the Stage 3/4/5 CKD patient population (~20 MM patients) at an annual treatment cost of US 2,000 (vs. ~US 3000 for Sevelamer), the estimated annual US sales will be US 1.2 billion. PUBLIC HEALTH RELEVANCE: Vidasym's phase I SBIR study will investigate the feasibility of using Vida-501, Vidasym's novel phosphate binder, to treat hyperphosphatemia and to improve renal and cardiovascular functions in chronic kidney disease (CKD). Globally gt 350 million individuals have CKD and this number is projected to increase to gt550 million by 2025. Although various modalities and substances are available for CKD, the mortality rate for CKD patients remains high (~33%) and the number of dialysis CKD patients keeps increasing. There is an urgent medical need for the development of an effective and novel resuscitation approach for the treatment of CKD. Hyperphosphatemia in CKD is linked to reduced kidney function, cardiovascular complications, and increased mortality. Limitations of current therapy demonstrate that a new treatment approach such as VS-501 to delay the time to dialysis and also reduce the mortality rate of CKD offers a significant opportunity for improved outcomes with substantial societal benefit.


Patent
Vidasym, Inc. | Date: 2012-10-12

Compositions comprising ferrous and/or ferric iron compounds and fiber in a complex, methods for preparing such compositions of matter, and the use thereof for treatment of adsorbing certain accessible targets in the gastrointestinal tract and in an extracorporeal system, are provided herein.

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