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Schreuer M.,UZ Brussel | Jansen Y.,UZ Brussel | Planken S.,UZ Brussel | Chevolet I.,UZ Gent | And 3 more authors.
The Lancet Oncology | Year: 2017

Background Patients with BRAFV600-mutant melanoma benefit from treatment with the combination of BRAF and MEK inhibitors, but resistance and disease progression develops in most patients. Preclinical studies and case studies have indicated that acquired resistance to BRAF inhibition can be reversible. We aimed to assess the anti-tumour activity of rechallenge with BRAF plus MEK inhibition in a prospective clinical trial. Methods In this open-label, single arm, dual-centre, phase 2 academic study in Belgium, patients aged 18 years or older with BRAFV600-mutant melanoma who had previously progressed on BRAF inhibitors (with or without MEK inhibitors) and were off-treatment for at least 12 weeks, were treated with dabrafenib 150 mg orally twice per day plus trametinib 2 mg orally once per day. The primary endpoint was the proportion of patients with investigator-assessed overall response at any time (defined as complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 confirmed on two occasions, at least 28 days after the first response was recorded). Analyses were done in the intention-to-treat population. The study is ongoing but no longer recruiting patients. This trial is registered with ClinicalTrials.gov, number NCT02296996. Findings Between April 5, 2014, and Feb 2, 2016, 25 patients were enrolled and initiated treatment in our study. A partial response was documented in eight (32%) of 25 patients (95% CI 15–54; six patients had progressed on previous treatment with dabrafenib plus trametinib and two patients had progressed on previous BRAF inhibitor monotherapy). Stable disease was noted in ten patients (40%; 95% CI 21–61). Rechallenge with dabrafenib plus trametinib was well tolerated. There were no unexpected or grade 4 or 5 treatment-related adverse events. Grade 3 adverse events occurred in two patients (8%; panniculitis [n=1] and pyrexia [n=1]). Serious adverse events which occurred on study were one patient with an Addison crisis triggered by grade 2 pyrexia symptoms that resolved after discontinuation of dabrafenib and trametinib. No patients died as a result of study treatment. Interpretation Rechallenge with dabrafenib plus trametinib showed anti-tumour activity in patients who had previously progressed on BRAF inhibitors and as such, rechallenge represents a potential new treatment option for these patients. Funding Vlaamse Liga Tegen Kanker, Novartis. © 2017 Elsevier Ltd


Ceulemans G.,UZ Brussel
Clinical nuclear medicine | Year: 2012

A 61-year-old man with severe chronic obstructive pulmonary disease presented to our hospital with recurrence of a right-sided spontaneous secondary pneumothorax. Thoracoscopic abrasion of the parietal pleura was performed, but an important air leak persisted. Presumed to originate from a bulla in the right upper lobe, bullectomy and pleural decortication were performed, but leakage remained. Lobectomy was considered, and quantitative ventilation/perfusion SPECT was performed to predict the functional outcome.Fused high-resolution CT/Tc Technegas images localized leakage not only to a bleb in the right upper lobe but also to the subcutaneous emphysema in the thoracic wall. The air leak resolved after conservative treatment.


Cosyns B.,UZ Brussel | Droogmans S.,UZ Brussel | Rosenhek R.,Medical University of Vienna | Lancellotti P.,University of Liège
Heart | Year: 2013

Drug-induced valvular heart disease (DIVHD) was first described in the 1960s. Initially, associations with ergot derivatives used for migraine prevention, or with anorectic drugs, were described. Drugs used for the treatment of Parkinson's disease and endocrine diseases, like hyperprolactinemia, may also induce VHD. More recently, the use of 3,4-methylendioxymetamphetamine (MDMA, ' Ecstasy') and benfluorexhave been found to be associated with DIVHD. Although some of these drugs were withdrawn from the market, several cases of patients requiring valve surgery even years after the cessation of therapy have been reported. DIVHD is not infrequent, may be severe, and has been described in association with several drugs. Even after drug cessation, long-term implications of this type of VHD may persist. The present review underlines the need for a careful evaluation of the associated clinical and echocardiographic risk factors to allow early recognition so as not to delay appropriate management.


Vandenplas Y.,UZ Brussel | De Greef E.,UZ Brussel
Acta Paediatrica, International Journal of Paediatrics | Year: 2014

Aim Cow's milk protein allergy (CMPA) is treated using an elimination diet with an extensive protein hydrolysate. We explored whether a thickened or nonthickened version was best for infants with suspected CMPA, which commonly causes regurgitation/vomiting. Methods Diagnosis of CMPA was based on a positive challenge test. We compared the efficacy of two casein extensive hydrolysates (eCH), a nonthickened version (NT-eCH) and a thickened version (T-eCH), using a symptom-based score covering regurgitation, crying, stool consistency, eczema, urticarial and respiratory symptoms. Results A challenge was performed in 52/72 infants with suspected CMPA and was positive in 65.4%. All confirmed CMPA cases tolerated eCH. The symptom-based score decreased significantly in all infants within a month, and the highest reduction was in those with confirmed CMPA. Regurgitation was reduced in all infants (6.4 ± 3.2-2.8 ± 2.9, p < 0.001), but fell more with the T-eCH (-4.2 ± 3.2 regurgitations/day vs. -3.0 ± 4.5, ns), especially in infants with a negative challenge (-3.9 ± 4.0 vs. -1.9 ± 3.4, ns). Conclusion eCH fulfilled the criteria for a hypoallergenic formula, and the NT-eCH and T-eCH formulas both reduced CMPA symptoms. The symptom-based score is useful for evaluating how effective dietary treatments are for CMPA. ©2014 The Authors. Acta Pædiatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Pædiatrica.


Neyns B.,UZ Brussel | Tosoni A.,Azienda USL Bellaria Maggiore Hospital | Hwu W.-J.,University of Texas M. D. Anderson Cancer Center | Reardon D.A.,Duke University
Cancer | Year: 2010

Temozolomide is an oral alkylating agent with established antitumor activity in patients with primary brain tumors and melanoma. The originally approved temozolomide dosing regimen is 150 to 200 mg/m2 per day (Days 1 to 5 every 28-day cycle [5 of 28 days]). However, extended dosing regimens (eg, 7 of 14 days, 21 of 28 days, 6 of 8 weeks, or continuously daily) allow for administration of a higher cumulative dose per cycle and have been shown to deplete O6-methylguanine-DNA methyltransferase, which may enhance cytotoxic activity. This article reviews efficacy and safety data from studies that investigated dose-dense temozolomide regimens in patients with recurrent glioma and advanced metastatic melanoma. The clinical benefits of these dose-dense regimens compared with the standard 5 of 28-day regimen have yet to be established. Although the toxicity profile of dose-dense temozolomide is generally similar to that of the standard 5 of 28-day regimen, it is associated with an increased incidence and severity of lymphocytopenia. The clinical management of temozolomide-associated lymphodepletion and the potential risks and benefits of extended dosing with temozolomide are discussed. Preclinical and clinical evidence suggests that temozolomide-associated lymphodepletion may enhance the host immune response to tumor-associated antigens and/or immunotherapy and may overcome tumor-mediated immunosuppression. Further studies exploring the clinical implications of lymphodepletion are warranted. © 2010 American Cancer Society.


Until an effective and especially disease-modifying treatment for Alzheimer's disease (AD) and vascular dementia (VaD) is available, the currently available pharmacological therapeutic arsenal aims at merely improving symptomatology. Health economic data make an important contribution to the planning of healthcare services and the estimation of the cost of drug reimbursement. As such, both for cholinesterase inhibitors and, to a lesser extent, for memantine it can be claimed that the direct cost of the drug itself is eclipsed by the cost savings associated with delaying institutionalization or delaying the time of progression into a more severe disease state. The present manuscript reviews several factors contributing to the costs of dementia, gives an overview of available studies claiming both the effectiveness and cost-effectiveness of current dementia treatments, and highlights strengths and weaknesses of the aforementioned studies. © 2014 IOS Press.


Vandenplas Y.,UZ Brussel
Nature Reviews Gastroenterology and Hepatology | Year: 2014

Paediatric GERD is complicated to manage, as symptoms are diverse and often difficult to interpret. In infants, regurgitation is a common physiological condition. Nevertheless, when it occurs frequently (>4 times per day) and causes the infant distress, parents often seek medical help. In children 2-10 years of age, GERD is often considered to cause extra-oesophageal symptoms, despite the absence of hard evidence. Diagnostic investigations often lack solid validation and the signs and symptoms of GERD overlap with those of cow's milk protein allergy and eosinophillic oesophagitis. Reassurance, dietary treatment and positional adaptations are recommended for troublesome infant reflux. Anti-acid medication, mainly PPIs, is over-used in infants even though, in many children, reflux is not an acid-related condition. Moreover, evidence is increasing that PPIs cause adverse events such as gastroenteritis and respiratory tract infections. Management in children older than 10 years is similar to that in adults. Using prokinetics to treat nonerosive reflux disease remains only a promising theoretical concept, as no such molecule is currently available. Today, the adverse effects of each prokinetic molecule largely outweigh its potential benefit. Laparoscopic surgery is indicated in children who have life-threatening symptoms or in cases of drug dependence. © 2014 Macmillan Publishers Limited. All rights reserved.


Luypaert R.,UZ Brussel | Sourbron S.,University of Leeds | De Mey J.,UZ Brussel
Magnetic Resonance in Medicine | Year: 2011

The two-compartment Tofts model (2CTM) has had widespread use in research and clinical practice. It assumes there is no broadening associated with the bolus transit through the capillary bed of the tissue under study. This assumption is often violated, with consequences that are hard to predict intuitively. The two-compartment exchange model is a generalization of 2CTM obtained by dropping the zero-broadening hypothesis, making it suitable for estimating the impact of violating this assumption. Using data simulated on the basis of the two-compartment exchange model, the correspondence between the hemodynamic parameters serving as input for the two-compartment exchange model and the parameters resulting from fitting the data with the 2CTM was investigated. The influence of tissue type and experimental setup was studied. Generally, a large tissue and setup dependent bias of the 2CTM fitting results with respect to the two-compartment exchange model input was observed. Extreme caution is needed when interpreting 2CTM data. Magn Reson Med, 2011. © 2010 Wiley-Liss, Inc.


SUWANEE, GA / ACCESSWIRE / December 15, 2016 / SANUWAVE Health, Inc. (OTC QB: SNWV) is pleased to announce that the Company, in partnership with Ortho-Medico, a member of B&Co, Herzele, Belgium, is sponsoring continuing clinical investigation on diabetic foot ulcers (DFU). This trial is expected to begin in January 2017, and will be conducted by the VUB (Free University of Brussels) and UZ Brussel (University Hospital). Earlier work in 2015 at this hospital found that DFU patients, treated in-home with dermaPACE system, responded positively to the treatment. This trial will take the home-care procedures, used in a limited basis, and extend them to a randomized, controlled trial of 100 subjects. The intent of this trial is to compare the effectiveness of in-home treatment of diabetic foot ulcers (DFUs) using dermaPACE as compared to in-home treatment of DFUs using standard of care only. This trial will help to provide evidence that dermaPACE can be used outside the clinical setting and in essence increase the potential for expanded sales in Europe. Ortho-Medico has long been SANUWAVE's partner in the European Union. With their strength, experience, and knowledge of the orthopedics and wound care market, they are well positioned to help expand SANUWAVE's market penetration via increased clinical presence and to continue to promote the Company's core products, dermaPACE, and orthoPACE systems. Commenting on today's announcement, Kevin A. Richardson II, SANUWAVE's Chairman of the Board, said, "We are very excited about this opportunity to investigate the use of dermaPACE in the home environment. We are equally excited that this opportunity is the first of many that SANUWAVE will partner with Ortho-Medico to help expand the clinical evidence associated with the use of dermaPACE system on diabetic foot ulcers." Added Jo Schops, General Manager of Ortho-Medico, "Our company has long been a proponent of dermaPACE and orthoPACE and this clinical trial will help to show the strong efficacy exhibited by the use of dermaPACE on DFU's. We are pleased to be partnering with SANUWAVE and the combined strength of our two companies will only help to expand market penetration in the European Union." SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA's Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets, and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron®, and orthoPACE® devices in Europe, Asia, and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for non-medical uses, including energy, water, food and industrial markets. Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico's final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico's success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions. This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company's product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company's ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement. For additional information about the Company, visit www.sanuwave.com. SUWANEE, GA / ACCESSWIRE / December 15, 2016 / SANUWAVE Health, Inc. (OTC QB: SNWV) is pleased to announce that the Company, in partnership with Ortho-Medico, a member of B&Co, Herzele, Belgium, is sponsoring continuing clinical investigation on diabetic foot ulcers (DFU). This trial is expected to begin in January 2017, and will be conducted by the VUB (Free University of Brussels) and UZ Brussel (University Hospital). Earlier work in 2015 at this hospital found that DFU patients, treated in-home with dermaPACE system, responded positively to the treatment. This trial will take the home-care procedures, used in a limited basis, and extend them to a randomized, controlled trial of 100 subjects. The intent of this trial is to compare the effectiveness of in-home treatment of diabetic foot ulcers (DFUs) using dermaPACE as compared to in-home treatment of DFUs using standard of care only. This trial will help to provide evidence that dermaPACE can be used outside the clinical setting and in essence increase the potential for expanded sales in Europe. Ortho-Medico has long been SANUWAVE's partner in the European Union. With their strength, experience, and knowledge of the orthopedics and wound care market, they are well positioned to help expand SANUWAVE's market penetration via increased clinical presence and to continue to promote the Company's core products, dermaPACE, and orthoPACE systems. Commenting on today's announcement, Kevin A. Richardson II, SANUWAVE's Chairman of the Board, said, "We are very excited about this opportunity to investigate the use of dermaPACE in the home environment. We are equally excited that this opportunity is the first of many that SANUWAVE will partner with Ortho-Medico to help expand the clinical evidence associated with the use of dermaPACE system on diabetic foot ulcers." Added Jo Schops, General Manager of Ortho-Medico, "Our company has long been a proponent of dermaPACE and orthoPACE and this clinical trial will help to show the strong efficacy exhibited by the use of dermaPACE on DFU's. We are pleased to be partnering with SANUWAVE and the combined strength of our two companies will only help to expand market penetration in the European Union." SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA's Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets, and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron®, and orthoPACE® devices in Europe, Asia, and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for non-medical uses, including energy, water, food and industrial markets. Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico's final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico's success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions. This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company's product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company's ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement. For additional information about the Company, visit www.sanuwave.com.


News Article | December 8, 2016
Site: www.prnewswire.co.uk

European and U.S. Hospitals Advance Adaptive Cancer Care with Image-Guided Radiation Therapy System Accuray Incorporated (NASDAQ: ARAY) announced today that leading hospitals in Europe and the United States are now treating patients with the new Radixact™ Treatment Delivery System, fully integrated with the new Accuray Precision™ Treatment Planning System and iDMS™ Data Management System. The first patient treatment in the world was administered at the University Hospital Brussels (UZ Brussel) in Belgium and in the United States at Froedtert & the Medical College of Wisconsin Froedtert Hospital in Milwaukee, Wisconsin, part of the Froedtert & MCW Cancer Network. The University Hospital Brussels (UZ Brussel) continues its legacy of innovation with the installation of the Radixact System, software, and treatment of the first patient worldwide. The smart new radiation therapy system represents the next generation in TomoTherapy® treatment delivery, significantly increasing treatment speed and ease of use. It enables clinicians to treat a wide range of cancer cases, from routine to complex, with precision and increased efficiency. "We are proud and excited to be the first hospital in the world to offer the new Radixact treatment option to our patients here in Brussels. This advanced technology represents another step forward toward optimal cancer care and improved quality of life for patients," said Prof. Mark De Ridder, Head of the Radiation Oncology Department, University Hospital Brussels (UZ Brussel, Vrije Universiteit Brussel). "The first patient who underwent a Radixact procedure received radiation to treat a metastatic mass in the neck. We are now actively treating patients across a broad range of cases and all treatments have gone smoothly. The precision software is straightforward, the image quality on the system is improved and dose delivery is efficient." Additionally, patients in France will have access to the Radixact System with its recent installation at the IUCT Oncopole - Institut Universitaire du Cancer de Toulouse in Toulouse, France. The hospital's clinical experts use the most current advances in cancer treatments to develop personalized programs which improve the quality of care they provide to patients. The Radixact System in the United States Multiple sites in the United States are now equipped with the Radixact System. Miami Cancer Institute, a part of Baptist Health South Florida, and Froedtert & MCW Cancer Network are the first to install the system. Froedtert Hospital treated the first patient in the United States and is the only cancer program in the Midwest currently offering treatment with the advanced Radixact platform. Froedtert and MCW physicians selected this system because it expands cancer treatment capabilities to improve patients' outcomes and quality of life. "For more than a decade, the Froedtert & MCW Cancer Network has been at the forefront of the evolution of image-guided and adaptive radiation therapy with the goal of providing more personalized treatments," said Christopher Schultz, MD, FACR, Medical College of Wisconsin Professor and Chairman of the Department of Radiation Oncology with the Froedtert & MCW Cancer Network. "The new Radixact™ platform tightly integrates the treatment planning function with the delivery of image-guided, highly conformal treatments and importantly, provides the tools to perform plan adaption when necessary." The Radixact System was also chosen as the newest approach in advanced radiation therapy treatment for the new state-of-the-art $430 million facility at Miami Cancer Institute. "Being the first in the Southeast to offer this sophisticated technology helps to further expand the comprehensive radiation treatments available to Miami Cancer Institute's patient population, giving our unique and integrated department the opportunity to deliver therapies best suited to treat a wide variety of cancers," said Minesh P. Mehta, M.D., Deputy Director and Chief of Radiation Oncology at Miami Cancer Institute. The Radixact® System leverages the TomoTherapy® System's efficient, daily low-dose fan beam MVCT image guidance and unique ring gantry architecture to deliver precise radiation treatments for more patients, every day. "We are excited about the early momentum in the adoption of this new radiation therapy platform. Our customers have already treated patients with the Radixact System, demonstrating their confidence in its value as a mainstream treatment option," said Joshua H. Levine, president and chief executive officer of Accuray. "These early adopters are leading the way for other hospitals and clinics seeking an innovative and effective technology to help them provide best-in-class radiation treatments for their cancer patients now and into the future." For further information on the Radixact System, visit http://www.accuray.com . For Important Safety Information please refer to http://www.accuray.com/safety-statement-radiation-treatment Accuray Incorporated (NASDAQ: ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company's leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit http://www.accuray.com. Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to clinical applications, clinical results, market acceptance of our new technologies, patient outcomes and Accuray's leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed from time to time under the heading "Risk Factors" in the company's report on Form 10-K, filed on August 24, 2016, the company's report on Form 10-Q, filed on November 1, 2016, and as updated periodically with the company's other filings with the SEC. Forward-looking statements speak only as of the date the statements are made and are based on information available to Accuray at the time those statements are made and/or management's good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.

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