Plegridy Observational Program

NCT ID: NCT02230969

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-12

Study Completion Date

2022-01-20

Brief Summary

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The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

Detailed Description

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Conditions

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Relapsing Forms of Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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peginterferon beta-1a

Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.

peginterferon beta-1a

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

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peginterferon beta-1a

Administered as specified in the treatment arm

Intervention Type DRUG

Other Intervention Names

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BIIB017 PEG IFN β-1a Plegridy PEGylated Interferon Beta-1a

Eligibility Criteria

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Inclusion Criteria

* Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).
* Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance.

Exclusion Criteria

* Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Homewood, Alabama, United States

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Gilbert, Arizona, United States

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Scottsdale, Arizona, United States

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Berkeley, California, United States

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California City, California, United States

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Hanford, California, United States

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Orange, California, United States

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Basalt, Colorado, United States

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Colorado Springs, Colorado, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Delray Beach, Florida, United States

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Atlanta, Georgia, United States

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Schaumburg, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Scarborough, Maine, United States

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Boston, Massachusetts, United States

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Lexington, Massachusetts, United States

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Worcester, Massachusetts, United States

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Southfield, Michigan, United States

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Golden Valley, Minnesota, United States

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St Louis, Missouri, United States

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Great Falls, Montana, United States

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Lebanon, New Hampshire, United States

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Freehold, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Port Royal, South Carolina, United States

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Knoxville, Tennessee, United States

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Bedford, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Milwaukee, Wisconsin, United States

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Camperdown, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Bedford Park, South Australia, Australia

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Fitzroy, Victoria, Australia

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Heidelberg, Victoria, Australia

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Linz, , Austria

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Vienna, , Austria

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Calgary, Alberta, Canada

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Saint John, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Sydney, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Cambridge, Ontario, Canada

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Toronto, Ontario, Canada

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Gatineau, Quebec, Canada

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Esbjerg, , Denmark

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Glostrup Municipality, , Denmark

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Sønderborg, , Denmark

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Nîmes, Gard, France

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Toulouse, Haute Garonne, France

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Montpellier, Herault, France

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Rennes, Ille Et Vilaine, France

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St-Malo, Ille Et Vilaine, France

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Le Mans, Sarthe, France

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La Seyne-sur-Mer, Var, France

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Poitiers, Vienne, France

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Mantes-la-Jolie, Yvelines, France

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Gonesse, , France

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Aalen, Baden-Wurttemberg, Germany

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Heidenheim, Baden-Wurttemberg, Germany

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Ladenburg, Baden-Wurttemberg, Germany

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Pforzheim, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Bamberg, Bavaria, Germany

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Munich, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Rüdersdorf, Brandenburg, Germany

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Bad Homburg, Hesse, Germany

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Butzbach, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Gelnhausen, Hesse, Germany

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Kassel, Hesse, Germany

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Göttingen, Lower Saxony, Germany

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Sande, Lower Saxony, Germany

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Stade, Lower Saxony, Germany

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Aachen, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Siegen, North Rhine-Westphalia, Germany

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Kandel, Rhineland-Palatinate, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

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Chemnitz, Saxony, Germany

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Leipzig, Saxony, Germany

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Itzehoe, Schleswig-Holstein, Germany

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Kiel, Schleswig-Holstein, Germany

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Altenburg, Thuringia, Germany

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Erfurt, Thuringia, Germany

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Jena, Thuringia, Germany

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Stadtroda, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Dublin, , Ireland

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Bergamo, , Italy

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Cagliari, , Italy

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Catanzaro, , Italy

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Florence, , Italy

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Genova, , Italy

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Messina, , Italy

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Milan, , Italy

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Napoli, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Blaricum, , Netherlands

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Breda, , Netherlands

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Hoorn, , Netherlands

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Guimarães, , Portugal

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Setúbal, , Portugal

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Cadiz, , Spain

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Córdoba, , Spain

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Málaga, , Spain

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Seville, , Spain

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Seville, , Spain

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Aarau, , Switzerland

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Basel, , Switzerland

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Bern, , Switzerland

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Lucerne, , Switzerland

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Irvine, Ayrshire, United Kingdom

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Truro, Cornwall, United Kingdom

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London, Greater London, United Kingdom

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Salford, Greater Manchester, United Kingdom

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Inverness, Highland Region, United Kingdom

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Leicester, Leicestershire, United Kingdom

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Glasgow, Strathclyde, United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Australia Austria Canada Denmark France Germany Ireland Italy Netherlands Portugal Spain Switzerland United Kingdom

Other Identifiers

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105MS401

Identifier Type: -

Identifier Source: org_study_id

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