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July 8, 2013

Mortality in patients with multiple sclerosis

Antonio Scalfari, MD, Volker Knappertz, MD, Gary Cutter, PhD, Douglas S. Goodin, MD, Raymond Ashton, PGCE, and George C. Ebers, MDAuthors Info & Affiliations
July 9, 2013 issue
81 (2) 184-192
https://doi.org/10.1212/WNL.0b013e31829a3388
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Abstract

Mortality in patients with multiple sclerosis (MS) is significantly increased compared with the general population. Many questions concerning survival in MS are still unanswered due to the difficulty of comparing information collected at different times and in different geographic areas. The increasing incidence of MS, the improvement in care of the chronically disabled, and different methodologies may explain the lack of coherence among studies' results. Reported times to death from birth and from disease onset/diagnosis are highly variable. Patients older at onset or with primary progressive course have shorter survival; however, data on sex and mortality are contradictory. Changes in sex ratio in MS over time represent one possible explanation. MS is the main cause of death in ≥50% of patients and the incidence of deaths not due to MS varies among countries. Particularly, suicide is substantially increased in patients with MS, and, despite its varying incidence, mainly due to “cultural bias,” it should be considered an MS-related cause of death. Recent results of the long-term follow-up study of interferon-β-1b demonstrated a significant reduction of mortality among treated patients. Notwithstanding its long latency, mortality is therefore an unambiguously valid long-term outcome in randomized controlled trials. It usefully combines the net impact of treatment efficacy on longevity and adverse events, which may reduce it.

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Information & Authors

Information

Published In

Neurology®
Volume 81 • Number 2 • July 9, 2013
Pages: 184-192
PubMed: 23836941

Copyright

© 2013 American Academy of Neurology.

Publication History

Received: October 30, 2012
Accepted: March 26, 2013
Published online: July 8, 2013
Published in print: July 9, 2013

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Disclosure

A. Scalfari reports no disclosures. V. Knappertz is a full-time employee of AstraZeneca and holds stock and stock options in the company. G. Cutter participates on Data and Safety Monitoring Committees for Apotek, Biogen-Idec, Cleveland Clinic, Glaxo Smith Klein Pharmaceuticals, Gilead Pharmaceuticals, Modigenetech/Prolor, Merck/Ono Pharmaceuticals, Merck, Neuren, Revalesio, Sanofi-Aventis, Teva, Vivus, NHLBI (Protocol Review Committee), National Institute of Neurological Disorders and Stroke, NMSS, and NICHD (OPRU oversight committee); has served as a consultant/on advisory boards/and received speaker honoraria from Alexion, Allozyne, Bayer, Celgene, Coronado Biosciences, Consortium of MS Centers (grant), Diogenix, Klein-Buendel Incorporated, Medimmune, Novartis, Nuron Biotech, Receptos, Spiniflex Pharmaceuticals, and Teva pharmaceuticals; and is employed by the University of Alabama at Birmingham and President of Pythagoras, Inc., a private consulting company located in Birmingham. D.S. Goodin has participated (or is currently participating) in several industry-sponsored clinical trials in MS. The sponsoring pharmaceutical companies for these trials have included (or do include) Ares-Serono, Merck-Serono, Novartis, Berlex Laboratories, Bayer-Schering Healthcare, Biogen-Idec, Schering AG, and Teva Neuroscience. He has also lectured at both medical conferences and in public on various aspects of the epidemiology, diagnosis, and management of MS. In many cases, these talks have been sponsored directly or indirectly by one or another of the above listed companies. He has also served as a temporary ad hoc consultant to several of these organizations on several occasions. R. Ashton is a salaried employee of PAREXEL MMS. G. Ebers has been a consultant for Bayer HealthCare and has received funding for research into the natural history of MS from Bayer HealthCare. He has served on a Data Monitoring committee for MedImmune, has had travel funded by EMD Serono, has received honoraria for speaking at meetings from EMD Serono, Danone, and Merck. Go to Neurology.org for full disclosures.

Study Funding

No targeted funding reported.

Authors

Affiliations & Disclosures

Antonio Scalfari, MD
From the Centre of Neuroscience (A.S.), Division of Experimental Medicine, Department of Medicine, Imperial College, Hammersmith Hospital, London, UK; Department of Neurology (V.K.), Heinrich Heine University Düsseldorf, Düsseldorf, Germany; AstraZeneca–Medimmune (V.K.), Gaithersburg, MD; Section on Research Methods and Clinical Trials (G.C.), University of Alabama at Birmingham, Birmingham; Department of Neurology (D.S.G.), University of California, San Francisco; PAREXEL MMS (R.A.), West Sussex; and Nuffield Department of Clinical Neurosciences (G.E.), John Radcliffe Hospital, University of Oxford, Oxford, UK.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
Italian Multiple Sclerosis Foundation (FISM)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Volker Knappertz, MD
From the Centre of Neuroscience (A.S.), Division of Experimental Medicine, Department of Medicine, Imperial College, Hammersmith Hospital, London, UK; Department of Neurology (V.K.), Heinrich Heine University Düsseldorf, Düsseldorf, Germany; AstraZeneca–Medimmune (V.K.), Gaithersburg, MD; Section on Research Methods and Clinical Trials (G.C.), University of Alabama at Birmingham, Birmingham; Department of Neurology (D.S.G.), University of California, San Francisco; PAREXEL MMS (R.A.), West Sussex; and Nuffield Department of Clinical Neurosciences (G.E.), John Radcliffe Hospital, University of Oxford, Oxford, UK.
Disclosure
Scientific Advisory Boards:
1.
employee of Astrazeneca Pharmaceuticals Employee of Teva Pharmaceuticals
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
Gene expression profiling for the discovery of molecular targets
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Bayer Healthcare Pharmaceuticals, Global Medical Affairs, CNS Astrazeneca Pharmaceutical Drug Development, CNS Teva Pharmaceuticals, Drug development, CNS
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
Gary Cutter, PhD
From the Centre of Neuroscience (A.S.), Division of Experimental Medicine, Department of Medicine, Imperial College, Hammersmith Hospital, London, UK; Department of Neurology (V.K.), Heinrich Heine University Düsseldorf, Düsseldorf, Germany; AstraZeneca–Medimmune (V.K.), Gaithersburg, MD; Section on Research Methods and Clinical Trials (G.C.), University of Alabama at Birmingham, Birmingham; Department of Neurology (D.S.G.), University of California, San Francisco; PAREXEL MMS (R.A.), West Sussex; and Nuffield Department of Clinical Neurosciences (G.E.), John Radcliffe Hospital, University of Oxford, Oxford, UK.
Disclosure
Scientific Advisory Boards:
1.
Participation of Data and Safety Monitoring Committees: Apotek Biogen-Idec Cleveland Clinic Glaxo Smith Klein Pharmaceuticals Gilead Pharmaceuticals Modigenetech/Prolor Merck/Ono Pharmaceuticals Merck Neuren Revalesio Sanofi-Aventis Teva Vivus NHLBI (Protocol Review Committee) NINDS NMSS NICHD (OPRU oversight committee) Consulting, Speaking fees & Advisory Boards: Alexion Allozyne Bayer Celgene Coronado Biosciences Consortium of MS Centers (grant) Diogenix Klein-Buendel Incorporated Medimmune Novartis Nuron Biotech Receptos Spiniflex Pharmaceuticals Teva pharmaceuticals
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Consortium of MS Centers, speaker honoraria; (2) Bayer, speaker honoraria (3) Teva, Speaker honoraria
Editorial Boards:
1.
(1) Multiple Sclerosis, Editorial Board, 2010-present
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Consulting, Speaking fees & Advisory Boards: Same as above.
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
(1) NINDS Grant with Multiple Sclerosis as the patient population (2) NARCOMS MS Patient Registry
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
No direct grants, but work on studies funded to the Consortium of MS Centers subcontracted for analysis of NARCOMS Registry.
Research Support, Government Entities:
1.
U01 NS 042685 (Cutter) 09/23/2005 - 08/31/2015 NIH/NINDS Thymectomy Plus Prednisone vs. Prednisone Alone in NonThymomatous Myasthenia Gravis This multinational clinical trial aims to assess the utility of thymectomy in treating nonthymomatous Myasthenia Gravis patients comparing surgery plus medications versus medications alone. U01 NS 45719 (Lublin) 09/30/2003 - 11/30/2013 NIH/NINDS A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients with Relapsing Remitting Multiple Sclerosis. The purpose of this project is to assess the impact of combination therapy in the treatment of RRMS. P30 DK 079337 (Agarwal) 09/01/2008 - 07/31/2013 NIH/NIDDK UAB/UCSD O'Brien Core Center for Acute Kidney Injury Research The major objective of this grant is to provide state-of-the-art core resources to address experimental questions for the advancement of AKI research P30-AI 027767 (Saag) 03/01/2009 - 02/28/2014 NIH/NIAID UAB Center for Aids Research is organized as a partnership between the University of Alabama at Birmingham and the Southern Research Institute. The primary purpose of this partnership is to generate interdisciplinary AIDS research efforts. This Center is responsible for planning, evaluating, managing and documenting a broad array of research activities within two institutions. Particular emphasis is placed upon linking clinical and basic science through the use of shared facilities and to translate as quickly as possible fundamental knowledge about AIDS and its related disorders into clinical treatment and prevention programs. No number assigned (Mark) 10/01/2009 - 09/30/2013 National Multiple Sclerosis Society Rehabilitating Extremity Use after Multiple Sclerosis This project compares CI therapy and complementary and alternative medicine treatments to determine their changes in the extent of more-affected arm use in the life setting and maximal movement ability in the laboratory for individuals with multiple sclerosis. R01 HD 064729 (Tita) 04/01/2010 - 03/31/2014 NIH/NICHD Caesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) Trial A multicenter randomized trial to determine the efficacy and safety of a modified (extended-spectrum) antibiotic prophylaxis strategy at cesarean delivery to reduce surgical site infections. UL1 RR 02577 (Kimberly) 05/19/2008 - 04/30/2013 NIH/NCRR UAB Center for Clinical & Translational Science (CCTS) The major goal of this Medicare United with Simple Clinical trials Expanded network (MUSCLE) is to conduct comparative effectiveness research by developing a “network of networks” for conducting pragmatic trials of therapeutics for chronic musculoskeletal diseases. R01 AG 021927 (Marson) 07/01/2010 - 06/30/2015 NIH/NIA Functional Change in Mild Cognitive Impairment (COINS) This R01 project investigates longitudinal change in higher order functional abilities in patients with MCI, and develops predictor models for clinical progression and conversion from MCI to dementia. U01 HL 102235 (Kinsella/Cutter) 09/07/2010 - 06/30/2013 NIH/NHLBI Phase II Trial of Sildenafil in Newborns with Persistent Pulmonary Hypertension This Phase II, multi-center, randomized, double-blind, placebo-controlled trial pursues the hypothesis that IV sildenafil will acutely reduce pulmonary artery pressure and improve oxygenation in near-term and term infants with PPHN, thus reducing the need for rescue therapy iNO and/or ECMO. P30 DK 074038 (Yoder) 09/30/2010 - 06/30/2015 NIH/NIDDK Hepato/Renal Fibrocystic Diseases Core Center. The University of Alabama at Birmingham Recessive Polycystic Kidney Disease Core Center (UAB RPKDCC) has established a NIDDK-funded, interdisciplinary center of excellence in PKD-related research, with specific emphasis on recessive PKD. Among the five Cores, the UAB RPKDCC includes the ARPKD Clinical and Genetic Resource, a Core resource designed to develop a unique set of clinical, genetic, and educational resources for ARPKD. The Core has three primary objectives: (1) to extend the observational study of ARPKD initiated by the North American ARPKD Database; (2) to provide a mechanism for genetic evaluation of patients with both classic ARPKD and unusual phenotypes of recessive PKD; and (3) to develop educational tools for physicians and patients regarding the natural history, cause, development and effects of the disease, genetic testing, and clinical trials applicable to ARPKD. R01 AG 037561 (Schneider) 04/01/2011 - 03/31/2014 NIH/NIA Synthesis of Longer-Term Alzheimer Disease Studies in Order to Model and Improve Clinical Trials Methods and Outcomes: Alzheimer Disease Clinical The results of this research will have a broad and lasting impact on trial designs for Alzheimer disease, mild cognitive impairment, and neurodegenerative disorders, and trials in which cognitive improvement is a targeted outcome. It will address important issues in the assumptions underlying the design decisions. This will lead to better understanding and improvement in the methods for future clinical trials and improve the likelihood for identifying effective treatments, as well as identifying ineffective treatments earlier in development. No number assigned (Cutter) 01/01/2004 - 12/31/2012 Consortium of MS Centers (CMSC) North American Research Consortium on Multiple Sclerosis (NARCOMS) The goals of this project are to facilitate a confidential way for patients to supply valuable information to researchers about their course of disease that may lead to more effective treatments and care for people living with MS, while reducing the time and cost of conducting studies; provide a worldwide research resource for people living with multiple sclerosis so they can provide information about themselves and their course of disease; and develop new collaborations between researchers, patients, and healthcare providers. UAB provides programming and analytic support for the NARCOMS registry. BAA-NIAID-DMID-NIHAI2010101 (Gnann/Kimberlin) 10/01/2011 - 09/30/2016 NIH/NIAID These contracts are to accomplish coordinating of various clinical trials with titles listed below: Safety Tolerability and Pharmacokinetics of CMX-001 in Renal Transplant Recipients with BKV Viremia: A Phase IIA Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study A Pharmacokinetic/Pharmacodynamic and Resistance Evaluation of Intravenous Ganciclovir in Premature Infants Adaptive Sequential Study Evaluating Prevention of Neonatal HSV: Detection of Maternal Shedding at Delivery Followed by Preemptive Antiviral Therapy in Exposed Neonates A Phase II 6 Weeks Oral Valganciclovir versus Placebo in Infants with Congenital CMV Infection and Hearing Loss 1U34AR062891-01 (Saag) 04/01/2012 - 03/31/2014 NIH/NIAMS Planning Grant for the Active ComparaTor Osteoporosis Large Simple Trial (ATLAST) The overall goals of this project are to collaborate with an advisory group of national osteoporosis, clinical trial, and community research experts to: (1) finalize the study protocol with respect to the study population, recruitment plan, primary and secondary outcomes, data collection/analysis plan; (2) develop a manual of procedures; and (3) develop effective linkages to Medicare data for long-term surveillance of participants.
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) Consortium of MS Centers
Stock/stock Options/board of Directors Compensation:
1.
Pythagoras, Inc. Sub S Corporation - President.
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
My daughter is an Attorney and has represented non medical clients in litigation
View all articles by this author
Douglas S. Goodin, MD
From the Centre of Neuroscience (A.S.), Division of Experimental Medicine, Department of Medicine, Imperial College, Hammersmith Hospital, London, UK; Department of Neurology (V.K.), Heinrich Heine University Düsseldorf, Düsseldorf, Germany; AstraZeneca–Medimmune (V.K.), Gaithersburg, MD; Section on Research Methods and Clinical Trials (G.C.), University of Alabama at Birmingham, Birmingham; Department of Neurology (D.S.G.), University of California, San Francisco; PAREXEL MMS (R.A.), West Sussex; and Nuffield Department of Clinical Neurosciences (G.E.), John Radcliffe Hospital, University of Oxford, Oxford, UK.
Disclosure
Scientific Advisory Boards:
1.
(1) Bayer Schering Pharma, (2) Merck Serono
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Occasional community lectures, symposia and/or academic talks sponsored by (1) Bayer Schering Pharma, (2) Teva Neuroscience, (3) Merck Serono, and (4) Novartis. In many cases, travel costs were reimbursed.
Editorial Boards:
1.
(1) International MS Journal, Editorial Board, 2000-2009
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
(1) Bayer Schering Pharma
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1) Bayer Schering, (2) Novartis
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
I have served as an expert witness on various neurologic topics, 2008-2009
View all articles by this author
Raymond Ashton, PGCE
From the Centre of Neuroscience (A.S.), Division of Experimental Medicine, Department of Medicine, Imperial College, Hammersmith Hospital, London, UK; Department of Neurology (V.K.), Heinrich Heine University Düsseldorf, Düsseldorf, Germany; AstraZeneca–Medimmune (V.K.), Gaithersburg, MD; Section on Research Methods and Clinical Trials (G.C.), University of Alabama at Birmingham, Birmingham; Department of Neurology (D.S.G.), University of California, San Francisco; PAREXEL MMS (R.A.), West Sussex; and Nuffield Department of Clinical Neurosciences (G.E.), John Radcliffe Hospital, University of Oxford, Oxford, UK.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Salaried employee of PAREXEL MMS.
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
View all articles by this author
George C. Ebers, MD
From the Centre of Neuroscience (A.S.), Division of Experimental Medicine, Department of Medicine, Imperial College, Hammersmith Hospital, London, UK; Department of Neurology (V.K.), Heinrich Heine University Düsseldorf, Düsseldorf, Germany; AstraZeneca–Medimmune (V.K.), Gaithersburg, MD; Section on Research Methods and Clinical Trials (G.C.), University of Alabama at Birmingham, Birmingham; Department of Neurology (D.S.G.), University of California, San Francisco; PAREXEL MMS (R.A.), West Sussex; and Nuffield Department of Clinical Neurosciences (G.E.), John Radcliffe Hospital, University of Oxford, Oxford, UK.
Disclosure
Scientific Advisory Boards:
1.
I have served on a data monitoring committee for MedImmune.
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Bayer HealthCare Pharmaceuticals, funding for travel to meetings; (2) Sanofi Aventis, speaker honorarium; (3) TEVA, speaker honoraria
Editorial Boards:
1.
(1) International MS Journal, Editorial Board, present; (2) Multiple Sclerosis, Editorial Board, present; (3) BMC Medical Genetics, Section Editor, 2010-present
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
(1) Biopartners, (2) Bayer Healthcare Pharmaceuticals, (3) Howrey LLP, (4) Heron Health
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1) Bayer Healthcare Pharmaceuticals
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) MS Society of Canada Scientific Research Foundation, 2008-2011
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
I have prepared several medico legal reports.
View all articles by this author

Notes

Correspondence to Dr. Ebers: [email protected]
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

Author Contributions

Antonio Scalfari: critical revision of the manuscript for intellectual content. Volker Knappertz: study concept and design, acquisition of data. Gary Cutter: critical revision of the manuscript for intellectual content. Douglas S. Goodin: critical revision of the manuscript for intellectual content. Raymond Ashton: critical revision of the manuscript for intellectual content. George C. Ebers: study concept and design, acquisition of data.

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