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13 records – page 1 of 2.

Characteristics associated with drug-induced liver injury from interferon beta in multiple sclerosis patients.

https://arctichealth.org/en/permalink/ahliterature266928
Source
Expert Opin Drug Saf. 2014 Oct;13(10):1305-17
Publication Type
Article
Date
Oct-2014
Author
Kaarina Kowalec
Elaine Kingwell
Eric M Yoshida
Ruth Ann Marrie
Marcelo Kremenchutzky
Trudy L Campbell
Mia Wadelius
Bruce Carleton
Helen Tremlett
Source
Expert Opin Drug Saf. 2014 Oct;13(10):1305-17
Date
Oct-2014
Language
English
Publication Type
Article
Keywords
Adult
British Columbia - epidemiology
Canada - epidemiology
Drug-Induced Liver Injury - epidemiology - etiology
Female
Follow-Up Studies
Humans
Immunologic Factors - adverse effects - therapeutic use
Interferon-beta - adverse effects - therapeutic use
Male
Middle Aged
Multiple Sclerosis - drug therapy
Proportional Hazards Models
Retrospective Studies
Risk factors
Sex Factors
Sweden - epidemiology
Time Factors
United States - epidemiology
Abstract
To identify and characterize drug-induced liver injury (DILI) associated with IFN-Ã? in multiple sclerosis (MS) using recommended criteria.
This retrospective, mixed methods design included a cohort of IFN-Ã? exposed MS patients from British Columbia (BC), Canada and a series of DILI cases from other Canadian provinces and two adverse drug reaction (ADR) networks (USA and Sweden). Associations between sex, age and IFN-Ã? product, and DILI were explored in BC cohort using Cox proportional hazard analyses. Characteristics, including the time to DILI, were compared between sites.
In BC, 18/942 (1.9%) of IFN-Ã? exposed MS patients met criteria for DILI, with a trend toward an increased risk for women and those exposed to IFN-Ã?-1a SC (44 mcg 3 Ã? weekly) (adjusted Hazard Ratios: 3.15;95% CI:0.72 - 13.72, p = 0.13 and 6.26;95%CI:0.78 - 50.39, p = 0.08, respectively). Twenty-four additional cases were identified from other sites; the median time to DILI was comparable between BC and other Canadian cases (105 and 90 days, respectively), but longer for the ADR network cases (590 days, p = 0.006).
Approximately 1 in 50 IFN-Ã? exposed patients developed DILI in BC, Canada. Identification of DILI cases from diverse sources highlighted that this reaction occurs even after years of exposure.
PubMed ID
25134421 View in PubMed
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Comparative analysis of first-year fingolimod and natalizumab drug discontinuation among Swedish patients with multiple sclerosis.

https://arctichealth.org/en/permalink/ahliterature276682
Source
Mult Scler. 2016 Jan;22(1):85-93
Publication Type
Article
Date
Jan-2016
Author
T. Frisell
L. Forsberg
N. Nordin
C. Kiesel
L. Alfredsson
J. Askling
J. Hillert
T. Olsson
F. Piehl
Source
Mult Scler. 2016 Jan;22(1):85-93
Date
Jan-2016
Language
English
Publication Type
Article
Keywords
Adult
Female
Fingolimod Hydrochloride - adverse effects - therapeutic use
Humans
Immunologic Factors - adverse effects - therapeutic use
Male
Middle Aged
Multiple Sclerosis - drug therapy
Natalizumab - adverse effects - therapeutic use
Registries
Severity of Illness Index
Sex Factors
Sweden
Time Factors
Treatment Outcome
Abstract
Natalizumab (NTZ) and fingolimod (FGL) are mainly used second line in relapsing-remitting multiple sclerosis (MS), although pivotal trials included mainly treatment-naïve patients.
This study aims to provide real-world data on safety and discontinuation rates.
Using IMSE, a drug monitoring registry for all newer MS drugs in Sweden, we analysed differences in baseline characteristics and 1-year drug survival for patients registered 2011-2013, initiating treatment with NTZ (n=640) or FGL (n=876). Among FGL initiators, n=383 (44%) had previously used NTZ (FGL(afterNTZ)).
Compared with NTZ, the FGL cohort was older and more often male (36/38 years, 24%/33% males). Baseline Expanded Disability Status Scale was similar across groups, but MS Severity Score was higher in NTZ patients, and Symbol Digit Modalities Test and MS Impact Scale (MSIS-29) was higher in FGL(afterNTZ) versus FGL(NTZ-naïve) patients. Proportion on drug after 1 year was high, NTZ=87%, FGL(NTZ-naïve)=83% and FGL(afterNTZ)=76%. Adverse events was the most frequent reason for discontinuing FGL (FGL(NTZ-naïve)=9%, FGL(afterNTZ)=12%), and was significantly higher than on NTZ (3%). In contrast, the proportion of patients stopping treatment due to lack of effect was more similar: NTZ=4%, FGL(NTZ-naïve)=3%, FGL(afterNTZ)=8%.
FGL and NTZ were both well tolerated, but FGL less so than NTZ, especially in patients switching to FGL from NTZ. Group differences were not explained by differences in recorded baseline characteristics.
PubMed ID
25921036 View in PubMed
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Incidence and Treatment of Patients Diagnosed With Inflammatory Bowel Diseases at 60 Years or Older in Sweden.

https://arctichealth.org/en/permalink/ahliterature291560
Source
Gastroenterology. 2018 02; 154(3):518-528.e15
Publication Type
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Date
02-2018
Author
Åsa H Everhov
Jonas Halfvarson
Pär Myrelid
Michael C Sachs
Caroline Nordenvall
Jonas Söderling
Anders Ekbom
Martin Neovius
Jonas F Ludvigsson
Johan Askling
Ola Olén
Author Affiliation
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden; Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. Electronic address: asa.hallqvist-everhov@ki.se.
Source
Gastroenterology. 2018 02; 154(3):518-528.e15
Date
02-2018
Language
English
Publication Type
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Keywords
Adolescent
Adrenal Cortex Hormones - adverse effects - therapeutic use
Adult
Age of Onset
Aged
Aged, 80 and over
Biological Products - adverse effects - therapeutic use
Child
Child, Preschool
Colectomy - adverse effects
Colitis, Ulcerative - diagnosis - epidemiology - therapy
Crohn Disease - diagnosis - epidemiology - therapy
Female
Gastrointestinal Agents - adverse effects - therapeutic use
Healthcare Disparities
Humans
Immunologic Factors - adverse effects - therapeutic use
Incidence
Infant
Infant, Newborn
Male
Middle Aged
Registries
Risk factors
Sweden - epidemiology
Time Factors
Treatment Outcome
Young Adult
Abstract
Diagnosis of inflammatory bowel diseases (IBD) is increasing among elderly persons (60 years or older). We performed a nationwide population-based study to estimate incidence and treatment of IBD.
We identified all incident IBD cases in Sweden from 2006 through 2013 using national registers and up to 10 matched population comparator subjects. We collected data on the patients' health care contacts and estimated incidence rates, health service burden, pharmacologic treatments, extra-intestinal manifestations, and surgeries in relation to age of IBD onset (pediatric,
PubMed ID
29102619 View in PubMed
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Increased incidence of Merkel cell carcinoma among younger statin users.

https://arctichealth.org/en/permalink/ahliterature123606
Source
Cancer Epidemiol. 2012 Oct;36(5):421-4
Publication Type
Article
Date
Oct-2012
Author
Helka Sahi
Virve Koljonen
Tom Böhling
Pertti J Neuvonen
Harri Vainio
Anne Lamminpää
Pentti Kyyrönen
Eero Pukkala
Author Affiliation
Department of Plastic Surgery, Helsinki University Hospital, Helsinki, Finland. helka.sahi@helsinki.fi
Source
Cancer Epidemiol. 2012 Oct;36(5):421-4
Date
Oct-2012
Language
English
Publication Type
Article
Keywords
Aged
Carcinoma, Merkel Cell - epidemiology
Causality
Cohort Studies
Confidence Intervals
Female
Finland - epidemiology
Follow-Up Studies
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
Immunologic Factors - adverse effects
Incidence
Male
Medical Record Linkage
Middle Aged
Population Surveillance
Risk assessment
SEER Program
Skin Neoplasms - epidemiology
Abstract
Statins (HMG-CoA-reductase inhibitors) are suggested to act as a predisposing factor for autoimmune diseases, have immunomodulatory effects, and possibly prevent some cancer types - the sum of these effects is unknown in cancers of viral aetiology, such as Merkel cell carcinoma (MCC). Aim of our study was to find out whether statin users in Finland have an increased incidence of MCC.
A cohort of 224715 male and 230220 female statin users during 1994-2007 was identified from the Prescription Register of the National Social Insurance Institution. This cohort was followed up through the Finnish Cancer Registry for MCC up to 2009.
There were altogether 50 cases of MCCs, while the expected number of cases, calculated on the basis of the MCC incidence in comparable Finnish population, was 39.9 (SIR 1.25, 95% CI 0.93-1.65). The standardized incidence ratio (SIR) for MCC in ages
PubMed ID
22683172 View in PubMed
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Infliximab and other immunomodulating drugs in patients with inflammatory bowel disease and the risk of serious bacterial infections.

https://arctichealth.org/en/permalink/ahliterature151001
Source
Aliment Pharmacol Ther. 2009 Aug;30(3):253-64
Publication Type
Article
Date
Aug-2009
Author
S. Schneeweiss
J. Korzenik
D H Solomon
C. Canning
J. Lee
B. Bressler
Author Affiliation
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 021205, USA. schneeweiss@post.harvard.edu
Source
Aliment Pharmacol Ther. 2009 Aug;30(3):253-64
Date
Aug-2009
Language
English
Publication Type
Article
Keywords
Adolescent
Adrenal Cortex Hormones
Adult
Aged
Aged, 80 and over
Anti-Inflammatory Agents - therapeutic use
Antibodies, Monoclonal - adverse effects
Bacterial Infections - chemically induced - etiology
British Columbia
Colitis, Ulcerative - complications - drug therapy
Crohn Disease - complications - drug therapy
Dose-Response Relationship, Drug
Female
Humans
Immunologic Factors - adverse effects
Immunosuppressive Agents - adverse effects
Male
Middle Aged
Risk factors
Treatment Outcome
Young Adult
Abstract
There remain concerns about the safety of infliximab therapy in patients with inflammatory bowel disease (IBD).
To assess the association between the initiation of infliximab and other immunomodulating drugs and the risk of serious bacterial infection in the treatment of IBD.
We assembled a cohort study of patients with IBD, including Crohn's disease (CD) and ulcerative colitis (UC). All patients initiating an immunomodulating drug between January 2001 and April 2006 were identified in British Columbia from linked health care utilization databases. Exposure of interest was initiation of infliximab or corticosteroids compared with initiation of other immunosuppressive agents, including azathioprine, mercaptopurine (MP) and methotrexate (MTX). Outcome of interest was serious bacterial infections requiring hospitalization, including Clostridium difficile.
Among 10 662 IBD patients, the incidence rate of bacteriaemia ranged from 3.8 per 1000 person-years (95% confidence interval 2.1-6.2) for other immunosuppressive agents to 7.4 (3.3-19.3) for infliximab with slightly higher rate for serious bacterial infections resulting in an adjusted relative risk 1.4 (0.47-4.24). Clostridium difficile infections occurred in 0/1000 (0-5.4) among 521 infliximab initiations and 14/1000 (10.6-18.2) for corticosteroids. Corticosteroid initiation tripled the risk of C. difficile infections (RR = 3.4; 1.9-6.1) compared with other immunosuppressant agents. This corticosteroid effect was neither dose-dependent nor duration-dependent. Bacteriaemia and other serious bacterial infections were not increased by corticosteroids or infliximab (5 events).
In a population-based cohort of patients with IBD, we found no meaningful association between infliximab and serious bacterial infections, although some subgroups had few events. Corticosteroid initiation increased the risk for C. difficile infections in these patients.
Notes
Comment In: Aliment Pharmacol Ther. 2010 Nov;32(9):1207-921039684
PubMed ID
19438424 View in PubMed
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One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population.

https://arctichealth.org/en/permalink/ahliterature114778
Source
J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38
Publication Type
Article
Author
Ronald Vender
Charles Lynde
Martin Gilbert
Vincent Ho
Sheetal Sapra
Melanie Poulin-Costello
Author Affiliation
Dermatrials Research, Hamilton, ON.
Source
J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38
Language
English
Publication Type
Article
Keywords
Adult
Canada
Confidence Intervals
Female
Headache - chemically induced
Humans
Immunoglobulin G - adverse effects - therapeutic use
Immunologic Factors - adverse effects - therapeutic use
Male
Middle Aged
Nasopharyngitis - chemically induced
Psoriasis - drug therapy
Quality of Life
Questionnaires
Receptors, Tumor Necrosis Factor - therapeutic use
Respiratory Tract Infections - chemically induced
Severity of Illness Index
Abstract
Although etanercept is well tolerated and effective in moderate-to-severe plaque psoriasis, data are limited in Canadian practice settings.
To assess the effectiveness and safety of etanercept in Canadian patients with moderate-to-severe plaque psoriasis (Physician Global Assessment [PGA] = 3) in routine practice.
A 1-year, multicenter, open-label trial of 246 patients enrolled from March 2006 to July 2009 was conducted. Patients received etanercept 50 mg subcutaneously twice weekly for 3 months and then 50 mg once weekly for 9 months. The primary end point was the proportion of patients achieving a PGA score = 2 at month 12. Secondary end points included the proportion of patients achieving PGA score = 2 at months 3, 6, and 9 and change from baseline at month 12 for Patient Global Assessment (PtGA), body surface area, and Dermatology Life Quality Index (DLQI). Adverse events were reported.
At month 12, 73.5% (95% CI 67.2-79.1) achieved a PGA score = 2. The response was similar regardless of the previous response to systemic or phototherapy. The proportion of patients achieving this score improved from 2.2% (95% CI 0.3-4.2) at baseline to 73.5% (95% CI 67.2-79.1) at 12 months. At 12 months, patients with a DLQI score of 0 or = 5-point improvement was 28.8% (95% CI 22.9-34.7) and 47.3% (95% CI 40.8-53.9), respectively. No new safety signals were reported.
The majority of this Canadian population demonstrated a meaningful improvement in PGA and DLQI scores over 1 year.
PubMed ID
23582167 View in PubMed
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[Progressive multifocal encephalopathy in a LED patient].

https://arctichealth.org/en/permalink/ahliterature265707
Source
Duodecim. 2015;131(10):950-3
Publication Type
Article
Date
2015
Author
Tapani Tikkakoski
Sinikka Ingo
Lillemor Julin
Sven Kanckos
Source
Duodecim. 2015;131(10):950-3
Date
2015
Language
Finnish
Publication Type
Article
Keywords
Antibodies, Monoclonal, Murine-Derived - adverse effects
Finland
Humans
Immunocompromised Host
Immunologic Factors - adverse effects
JC Virus
Leukoencephalopathy, Progressive Multifocal - immunology - virology
Abstract
Progressive multifocal encephalopathy (PML) is a rare demyelinating disease of the central nervous system, caused by the reactivation of the JC virus in the body during immunosuppression. The use of monoclonal antibodies predisposes to PML, and the epidemiology of the disease has changed. We describe the first PML published from Finland and associated with rituximab treatment in a LED patient.
PubMed ID
26237874 View in PubMed
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Recurrence or rebound of clinical relapses after discontinuation of natalizumab therapy in highly active MS patients.

https://arctichealth.org/en/permalink/ahliterature260262
Source
J Neurol. 2014 Jun;261(6):1170-7
Publication Type
Article
Date
Jun-2014
Author
Per Soelberg Sorensen
Nils Koch-Henriksen
Thor Petersen
Mads Ravnborg
Annette Oturai
Finn Sellebjerg
Source
J Neurol. 2014 Jun;261(6):1170-7
Date
Jun-2014
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Antibodies, Monoclonal, Humanized - adverse effects
Denmark
Female
Humans
Immunologic Factors - adverse effects
Longitudinal Studies
Male
Middle Aged
Multiple Sclerosis - chemically induced - drug therapy
Recurrence
Retrospective Studies
Time Factors
Treatment Outcome
Young Adult
Abstract
A number of studies have reported flare-up of multiple sclerosis (MS) disease activity after cessation of natalizumab, increasing to a level beyond the pre-natalizumab treatment level. Our aim was to describe the development in clinical disease activity following cessation of natalizumab therapy in a large unselected cohort of highly active patients. We studied 375 highly active patients who had suffered at least two significant relapses within 1 year or three relapses within 2 years, or had been treated with mitoxantrone for highly active disease. All patients had discontinued therapy with natalizumab after at least 24 weeks on therapy, and had been followed 3-12 months (mean 8.9 months) after cessation of natalizumab therapy. The annualised relapse rate before start of natalizumab therapy was 0.94 (95 % confidence interval [CI] 0.88-1.00), 0.47 (95 % CI 0.43-0.52) during natalizumab therapy, 0.63 (95 % CI 0.51-0.76) 1-6 months after natalizumab and 0.55 (95 % CI 0.42-0.70) 7-12 months after natalizumab. However, 83 (22 %) of the patients could be classified as showing rebound of relapses, defined as a higher individual relapse rate after cessation of natalizumab than before natalizumab. These patients had a higher annualised relapse rate during natalizumab therapy. For the whole patient group, the relapse rate after discontinuation did not exceed the pre-natalizumab relapse rate at any time, but 22 % of the patients showed rebound of relapses after discontinuation of natalizumab.
PubMed ID
24728334 View in PubMed
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Rituximab in multiple sclerosis: A retrospective observational study on safety and efficacy.

https://arctichealth.org/en/permalink/ahliterature282618
Source
Neurology. 2016 Nov 15;87(20):2074-2081
Publication Type
Article
Date
Nov-15-2016
Author
Jonatan Salzer
Rasmus Svenningsson
Peter Alping
Lenka Novakova
Anna Björck
Katharina Fink
Protik Islam-Jakobsson
Clas Malmeström
Markus Axelsson
Mattias Vågberg
Peter Sundström
Jan Lycke
Fredrik Piehl
Anders Svenningsson
Source
Neurology. 2016 Nov 15;87(20):2074-2081
Date
Nov-15-2016
Language
English
Publication Type
Article
Keywords
Adult
Disability Evaluation
Female
Follow-Up Studies
Humans
Immunologic Factors - adverse effects - therapeutic use
Magnetic Resonance Imaging
Male
Middle Aged
Multiple Sclerosis, Chronic Progressive - diagnostic imaging - immunology
Multiple Sclerosis, Relapsing-Remitting - diagnostic imaging - drug therapy - immunology
Retrospective Studies
Rituximab - adverse effects - therapeutic use
Sweden
Treatment Outcome
Abstract
To investigate the safety and efficacy of rituximab in multiple sclerosis (MS).
In this retrospective uncontrolled observational multicenter study, off-label rituximab-treated patients with MS were identified through the Swedish MS register. Outcome data were collected from the MS register and medical charts. Adverse events (AEs) grades 2-5 according to the Common Terminology Criteria for Adverse Events were recorded.
A total of 822 rituximab-treated patients with MS were identified: 557 relapsing-remitting MS (RRMS), 198 secondary progressive MS (SPMS), and 67 primary progressive MS (PPMS). At baseline, 26.2% had contrast-enhancing lesions (CELs). Patients were treated with 500 or 1,000 mg rituximab IV every 6-12 months, during a mean 21.8 (SD 14.3) months. During treatment, the annualized relapse rates were 0.044 (RRMS), 0.038 (SPMS), and 0.015 (PPMS), and 4.6% of patients displayed CELs. Median Expanded Disability Status Scale remained unchanged in RRMS (p = 0.42) and increased by 0.5 and 1.0 in SPMS and PPMS, respectively (p = 0.10 and 0.25). Infusion-related AEs occurred during 7.8% of infusions and most were mild. A total of 89 AEs grades =2 (of which 76 infections) were recorded in 72 patients. No case of progressive multifocal leukoencephalopathy was detected.
This is the largest cohort of patients with MS treated with rituximab reported so far. The safety, clinical, and MRI findings in this heterogeneous real-world cohort treated with different doses of rituximab were similar to those reported in previous randomized controlled trials on B-cell depletion therapy in MS.
This study provides Class IV evidence that for patients with MS, rituximab is safe and effective.
Notes
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PubMed ID
27760868 View in PubMed
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Second malignancies in patients with hairy cell leukemia in british columbia: a 20-year experience.

https://arctichealth.org/en/permalink/ahliterature204898
Source
Blood. 1998 Aug 15;92(4):1160-4
Publication Type
Article
Date
Aug-15-1998
Author
W Y Au
R J Klasa
R. Gallagher
N. Le
R D Gascoyne
J M Connors
Author Affiliation
Division of Medical Oncology, British Columbia Cancer Agency and the University of British Columbia, Vancouver, Canada.
Source
Blood. 1998 Aug 15;92(4):1160-4
Date
Aug-15-1998
Language
English
Publication Type
Article
Keywords
Adult
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic - adverse effects - therapeutic use
British Columbia - epidemiology
Cladribine - adverse effects - therapeutic use
Combined Modality Therapy
Comorbidity
Female
Humans
Immunologic Factors - adverse effects - therapeutic use
Incidence
Interferons - adverse effects - therapeutic use
Leukemia, Hairy Cell - epidemiology - therapy
Life tables
Male
Middle Aged
Neoplasms, Second Primary - epidemiology
Pentostatin - adverse effects - therapeutic use
Prospective Studies
Risk
Smoking - epidemiology
Splenectomy - adverse effects
Abstract
The purpose of this study was to compare the relative risk of second malignancies in a cohort of patients with hairy cell leukemia (HCL) against the normal population. Potential effects of type of treatment and duration of follow-up and the site distribution of cancer were also examined. Between 1976 and 1996, 117 patients were diagnosed with HCL in British Columbia who were referred to the British Columbia Cancer Agency (BCCA) for treatment. All additional malignancies were traced using a provincial population-based cancer registry and follow-up records from the BCCA. There were 90 men and 27 women. Median age at diagnosis was 53 years. The median follow-up time was 68 months. Twenty-three patients underwent primary splenectomy, 65 received interferon alpha, 24 deoxycoformycin, and 67 cladribine (2-chlorodeoxyadenosine). Thirty-six patients had an additional malignancy (30.7%) with a total of 44 tumors. Six patients (5.1%) had two or more malignancies. Twenty-five patients had malignancies diagnosed after HCL (21.3%), three concurrent with HCL (2.6%), and 12 preceding HCL (10.2%). Second tumors (n = 28 tumors) occurred at a median of 40 months after HCL (range, 3 to 167). The relative rate (RR) of second malignancy among men and women was 2.91 (P
PubMed ID
9694703 View in PubMed
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13 records – page 1 of 2.