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    Archived pages: 99 . Archive date: 2013-10.

  • Title: e-capture.net - The secure EDC solution
    Descriptive info: .. e-capture.. net.. The secure EDC solution.. HOME.. BLOG.. SUPPORT.. CONTACT.. Online data capture platform to collect clinical trial data and to generate custom reports.. The e-capture.. net platform features an easy-to-use web interface, complex validation, advanced reporting and secure access throughout the whole application.. Login.. Login ID.. Password.. Browser requirement check.. JavaScript is.. disabled.. Cookies are.. unknown.. Forgot your password?.. |.. Contact support.. Electronic Data Capture.. Collect clinical study data through an easy to use web interface.. Advanced Validation.. net allows you to implement very  ...   more.. Secure Access.. net is encrypted with SSL to ensure security of all your clinical data.. studies.. in.. countries.. unique CRF forms.. active user accounts.. total of.. subjects enrolled.. over.. completed CRF forms.. completed questions.. Blog.. Social.. Home.. Support.. Contact.. Twitter.. Follow @eCapture.. Newsletter.. Subscribe to our mailing list to receive updates and news about e-capture.. Email address.. Guarantees.. ISO 9001:2008 certified.. Secure access via https.. 21 CFR part 11.. compliant.. ISO 27001:2005 certified.. is a registered trademark of.. e-novex BVBA.. 2008 -.. All rights reserved..

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  • Title: e-capture.net | The secure EDC solution
    Descriptive info: Blog.. Older posts.. net version 2.. 6 released.. Posted on.. December 7, 2012.. by.. Stijn Van Loo.. Version 2.. 6, the latest installment of.. , will be deployed to production at 5:00PM CET.. In the past we always released a new update every three months, but we have decided since then to decrease the number of releases per year from four to two.. This allows us to concentate on new and exciting innovations.. This update includes the following items:.. User Management.. This is a feature that has been on our whishlist for quite some time.. now gives the sponsor full control over user management.. User Management in e-capture.. Designated user profiles will have the ability to create new users, reset passwords, temporarily disable certain profiles or unblock users who forgot their password.. Contact your project manager if you want to enable this for your study.. Queries on Basic Patient Information.. Quering the Basic Patient Information form.. This new release includes an update to the query functionality.. For new studies.. , it is now possible to query the data items on the patient enrollment screen.. When a faulty date of birth or patient gender has been entered, this can now be flagged by adding a query to it, so the issue can be corrected.. Job list history.. The job list contains an overview of long-running tasks you have requested in the past, such as PDF export for an entire patient, a full data export in SAS, etc.. For technical reasons, we need to limit the job list to only contain tasks for the past 6 months.. If you need a specific task that was created over 6 months ago, contact our support department and they ll be happy to extract it from our backup environment.. Posted in.. Releases.. |.. 1 Comment.. Dive into SDTM.. September 18, 2012.. Michael Golichenko.. CDISC - Clinical Data Interchange Standards Consortium.. Last week I had the privilege to attend an interesting two day CDISC training about SDTM v3.. 1.. 2.. This training consisted of:.. A detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design.. A discussion of common implementation issues.. Exercises including the annotation of CRFs and the creation of datasets that reinforce attendees understanding of the SDTM and the SDTM Implementation Guide for clinical data.. SDTM (Study Data Tabulation Model) is a specification in the FDA electronic Common Technical Document (eCTD) Guidance as the model for submitting clinical and preclinical data to the FDA.. The first day we went through what SDTM is, what documents you need that will help you collect data correctly, the structure of the collected data and of course how to collect data from a CRF following the SDTM Implementation Guide.. Because SDTM is a very flexible standard and can be extended to cover the needs of every study, we saw how to correctly extend the base SDTM structure, collect the data and store it the right way.. On the second day we discussed how to set a relationship between stored data and how to correctly refer to data in one domain (dataset) that has more information about data in another domain (dataset).. We also covered how to setup a clinical trial with Trial Design.. This helps in defining the flow of your study and what SDTM domains (datasets) are needed to collect data.. Because CDISC standards are becoming more and more prevalent in corporate and government organizations, this knowledge is very useful for us at.. e-novex.. and can be used in our upcoming projects.. Here SDTM will be one of the supported formats for importing and exporting, to help sponsors submit their study data to FDA or exchange their clinical data between supported platforms.. If you would like to know more about SDTM, additional information can be found:.. In of our previous blog posts:.. CDISC and Medical Devices.. On the CDISC website.. http://www.. cdisc.. org/sdtm.. Industry.. ,.. Technology.. Leave a comment.. New standard reports.. August 30, 2012.. Joke Goffart.. It s been a while since our last post.. During the summer we have continued to work hard to make.. the most flexible and user-friendly EDC platform on the market.. Following a suggestion from one of our clients, we have added two new reports to our standard reports list: The Memo Report and the Missing Data Report:.. Standard reports in e-capture.. The Memo Report gives an overview of all memo fields that have been entered throughout the CRF.. Memo fields can be used to communicate additional information between sites and monitors, without creating a query.. In.. you can set a question to Missing if the answer is unknown or cannot be collected.. This is done by right-clicking on the question and selecting Set missing.. This information is very important for a sponsor.. That s why we created the Missing Data Report.. A big Thank you! once again to our end-users who continue to help us to improve our product and maintain the high quality of the clinical data for their trails.. Announcements.. 5 released.. June 8, 2012.. It s been another three months since our latest release and we re excited to share with you what we have included in this release:.. Dashboard.. The homepage now displays a dashboard which provides a status overview of the different patients and / or centers you have access to.. A progress bar indicates the overall status in terms of data entry.. If you hover over the Progress column, a pop-up appears with additional information.. Query actions.. We received a lot of feedback about handling queries and the query text that has to be entered.. The query text is often a standard response and selecting a pre-filled option greatly increases query handling time.. Therefore we created a few different default responses for creating, answering and closing queries.. Custom reports visibility.. A user profile can now have read-only access to custom reports.. In the past you either had access to the reports module or not.. Because it might be beneficial to let other users consult and export reports, the read-only access to custom reports was added.. Printing entire patient eCRFs.. It s now possible to print all eCRFs for all patients in a specific center, or even for all patients in all centers.. When clicking on either Studies or Centers from the navigation, you can select the Print patients link to start the process in the background.. When the prints are ready, your job list will indicate this with a small  ...   real-time communication between the client and the web server.. This can be useful whenever a user needs to be notified of something that happened in the system without reloading the entire web page.. It was again a very informative conference like last year.. I hope to be there again next year so we can continue to stay up-to-date about all the latest developments that come out of Redmond.. Update to session time-out.. February 1, 2012.. Following the v2.. 3 release of.. , we included a feature called lock screen.. Combined with the standard session timeout, this feature safeguards your clinical data from unauthorized access.. Screen lock in e-capture.. Initially the lock screen appeared after 10 minutes of inactivity.. Another 20 minutes later the user would be logged out if no further activities (eg.. typing or mouse gestures) were performed.. The overall feedback was that the 10 minute timeout was a bit too short.. People working with our.. platform are performing other tasks simultaneously, which is often the case in a hospital setting.. If they returned to.. some time later, they were either confronted with the lock screen or they had been logged out due to inactivity.. Since this is very valuable feedback, we wanted to know what the general consensus would be about this matter.. We immediately started a Linkedin discussion about the subject, and quickly learned that there is no legislative or regulatory requirement concerning this matter.. Both our end-user feedback and the comments on the LinkdedIn discussion showed that a time-out of 20 minutes is considered adequate for an EDC application.. Additionally, we also extended the total session timeout to 60 minutes.. This allows the.. end-users to easily resume their session while work on other things or being called away for a few minutes, and meanwhile protecting any confidential data that might be on their screen.. We hope you appreciate our efforts, let us know in the comments!.. At the bottom of the ocean.. January 24, 2012.. Peter Bossier.. The Internet, we are all so accustomed to it, connect to it on a daily basis, enjoy whatever we consult, enter and share.. We’re many (.. http://en.. wikipedia.. org/wiki/List_of_Internet_users_by_country.. ) and increasing.. The Internet, written with a capital I, is considered so important that access is a legal right in some countries (e.. g.. Finland) but at the same time (partially) blocked in many others.. Be sure to have a look at the state of the Internet today at.. onlineschools.. org/state-of-the-internet/soti.. html.. Some time ago I was wondering how all of us get connected.. There is a good introduction on the Internet on Wikipedia (.. org/wiki/Internet.. ), but I specifically wanted to know how the continents are connected (.. org/wiki/Internet_backbone.. ).. There are actually two ways of connecting regions, first one are fiber optic cables under the oceans, second the use of satellite communication.. For example, the.. Southern Cross Cable.. connects the US West-coast with Australia.. Other ones are the Atlantic Crossing 1 and 2 between Europe and the East-coast of the US, and the Sub-Saharan Undersea Cables between Europe and Africa.. You can find the list of international submarine communication cables on.. Wikipedia.. as well.. Submarine cables are laid using special cable layer ships and can cost several hundreds of millions of dollars to construct.. A global overview of the Internet’s undersea world also shows the impact of a ship’s anchor accidently cutting two cables in Alexandria in 2008, reducing internet capacity in Asia by 75% for several days.. In Irvine, Anjay Bajaj s business felt the effects immediately.. His team in New Delhi processes 600 medical forms a day for U.. S.. health clinics and ships the data over the Internet.. That slowed as Bajaj scrambled to figure out what had happened.. It s worrying that a ship in the Middle East can cut two cables and there is a doctor in the U.. who is not going to get his reports out on time, said Bajaj, a director at Altos Inc.. However, the Internet did not go down, the Internet was designed not to have a single point of failure.. You might think submarine cabling is a pretty recent technology, but it already started in 1850 between England and France and a few years later a transatlantic telegraph cable was in use.. By 1900 most of the world was already submarine connected.. At that time, only copper wiring was available, now all submarine cabling is fiber optic.. The cable itself is about 7 cm diameter and weighs 10 kg per meter.. Currently only a fraction of the Internet communication between continents is by low-orbit satellites because of its limited bandwidth and high cost.. They are mainly used for mobile applications such as communications to ships, vehicles, planes and hand-held terminals, for TV and radio broadcasting and internet access in rural areas.. I hope hope you enjoyed this little introduction into the wonderful world of the physically connected word wide web!.. On to the next year.. December 27, 2011.. As the year slowly draws to an end, we look back at 2011 with a very positive sentiment.. We have made great advancements with.. and the platform has matured a lot in the past 12 months.. Here s to a wonderful 2012!.. We managed to put in place a steady.. release cycle.. for the product, allowing us to introduce new features and improvements every 3 months.. We hired an additional developer to help us expand.. to become a truly innovative web-based product for clinical data collection.. At.. , the company behind.. , we witnessed some significant changes as well.. We further expaned our team with a lot of talented individuals, we had our first.. staff meeting.. in October.. Last but certainly not least, we are very proud to announce that as of January 2012 our company is also.. ISO 27001.. certified, on top of our.. ISO 9001.. ceritification which is re-assessed every year.. All of us at.. would like to thank you for your continued trust and support in making.. a better product that is being improved constantly by its end-users.. We which you all the best for 2012 and hope to service you even better than before.. Culture.. Search.. Search for:.. Recent Posts.. Archives.. December 2012.. September 2012.. August 2012.. June 2012.. April 2012.. March 2012.. February 2012.. January 2012.. December 2011.. November 2011.. October 2011.. September 2011.. August 2011.. July 2011.. June 2011.. May 2011.. April 2011.. March 2011.. February 2011.. Categories.. Social media.. Email address.. ISO 27001:2005 eligible..

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  • Title: e-capture.net
    Descriptive info: Support.. Please send us your question by completing the form below.. We will contact you within 24 hours after receipt.. Alternatively, you can also contact us via e-mail at.. support[at]e-novex.. For urgent issues, give us a call at.. +32 3 292 63 20.. Name.. E-mail.. Study.. Category.. --Please select--.. Inquiry.. Feature Request.. Report a Bug.. Other.. Your question..

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  • Title: e-capture.net
    Descriptive info: Contact.. If you would like to receive additional information, or have a specific question for us, don't hesitate to contact us by filling out the form below.. You can also reach us via telephone, fax, e-mail or regular post.. Question.. Justitiestraat 6B.. 2018 Antwerp.. BELGIUM.. T +32 3 292 63 20.. F +32 3 292 63 21.. info[at]e-novex.. e-novex.. Route description..

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  • Title: e-capture.net | The secure EDC solution | Page 2
    Descriptive info: Newer posts.. 3 released.. December 8, 2011.. It s been another three months since our latest release.. Tonight at 6:00PM CET, v2.. 3 will be deployed to production, and here s an overview of the most important features:.. Feedback messages.. Feedback messages in e-capture.. Throughout the.. application, we have started incorporating feedback messages.. They give a visual confirmation of the action that you have performed.. Currently, feedback messages only appear at form-level, eg.. when editing a CRF form and clicking the Save or Cancel button.. Feedback messages will auto-hide after a few seconds, or you can click the Close icon in the top-right corner.. Lock screen.. Data protection is a very important aspect in clinical trials, especially.. in Europe.. Therefore we have created a Lock screen functionality, that allows you to hide your screen in.. , to prevent unauthorized access to your trial data.. Simply click the Lock screen link on the top-right of your screen to try out this new feature.. Your screen will be entirely grayed out, preventing anyone passing by to look at the confidential trial data on your screen.. This locking mechanism also appears when you ve been inactive for 10 minutes, which means your session has timed out.. You can unlock your screen by providing your password, or you can choose to logout.. Study-specific values.. Following the suggestions of our clients and end-users, we can now display study-specific values in the header of the navigation screen.. Different studies require different endpoints and data items to be monitored carefully, and this new feature fullfills this need seamlessly.. Apart from these features, we have also resolved a few bugs that our clients reported to us.. We want to thank everyone using our application for helping us making.. a better application every day.. Feel free to leave a comment to let us know how you like these new features.. EDC market tool.. November 28, 2011.. We are featured on the new and improved EDC Market Tool that is available at.. http://edcmarket.. appspot.. The author of this website has combined all current EDC platforms and their companies in an easy-to-use and intuitive comparison tool.. EDC Market tool.. This is a great reference tool when you re looking for an EDC platform with very specific needs.. The Systems tab on the website allows you to filter on the specific EDC requirements for your project.. Contact information and a link to application and company website are provided for each platform.. The tool also has a section called Recent comparisons where all the latest comparisons appear that have been conducted by visitors of the website.. In addition, the author also maintains a blog where articles related to EDC and eClinical are posted regularly.. Go try it out for yourself at.. com/edcsystems.. Change of address.. November 22, 2011.. New office at Justitiestraat.. As of November 14th 2011,.. has moved to a new office, along with our colleagues of.. genae.. Our new address is.. We will also send out an official change of address e-mail to all our clients.. But we also wanted to let all our end-users know that we can service you even better in the future.. If you have any additional questions, give us a call at +32 3 292 63 20 or send an e-mail at.. info@e-novex.. Annual staff meeting.. November 3, 2011.. Last week we held our annual staff meeting at.. right here in Antwerp.. It was an interesting day full of great presentations and team-building activities.. One of the project managers at our sister company.. genae associates.. provided us with some useful feedback about.. and how it s being used at their company.. We are in the process of incorporating some of the suggested features into our product roadmap.. We also discussed some of the emerging technologies such as.. HTML5.. and.. CSS3.. , which we will start incorporating into.. as we re always looking to improve our product.. The development team is also adopting new architectures and methodologies, such as.. MVC.. and and.. test-driven development.. An important part of this staff meeting was simply being together and enjoying eachother s company.. We are a small team but everyone is very dedicated in what they do, and this was a great opportunity to emphasize this.. To underline this great athmosphere and take it to the next level, we decided to list down a few core values for.. : Values that we live by and that can be applied to our every day work.. As soon as we have finalized the list, we will publish this on our blog for everyone to consult.. Because one important core value stands out here at.. : transparancy and openness.. We want our customers to know exactly what it is that defines our company culture.. Custom reports updated.. October 11, 2011.. As of today, the custom reporting tool has a few additional variables that you can choose for every CRF form in the study you re working on.. The list of new variables is as follows:.. Updated custom reports.. - Last update date.. - Last update user ID.. - Date of occurrence (multiple occurrence form).. - Description of occurrence (multiple occurrence form).. - Lock date.. - Locked by.. - Freeze date.. - Freeze by.. - Date signed.. - Signed by.. For all these variables,  ...   Numerous features that are present in.. today we re suggested by people using the application.. Just last week we received an interesting request from one of our existing customers.. Study documents in e-capture.. For every study on.. , we offer the possibility to upload documents, such as newsletters or other study-specific information.. We were asked if these documents could be featured more prominently on the frontpage, after logging on.. We quickly included this feature in our product roadmap, and the update was released today.. We really appreciate these kind of improvement suggestions, thanks again and keep sending them in!.. August 25, 2011.. Last week we followed an.. interesting webinar.. on the new CDISC medical device data models.. For those of you who are unfamiliar with.. CDISC.. you can read the following on their website:.. “CDISC is a global,.. open.. , multidisciplinary,.. non-profit.. organization that has established.. standards.. to support the acquisition, exchange, submission and archive of.. clinical research data.. and metadata.. The CDISC mission is to develop and support.. global, platform-independent data standards.. that enable information system interoperability to improve medical research and related areas of healthcare.. CDISC standards are.. vendor-neutral.. , platform-independent and freely available via the CDISC website.. ”.. org/mission-and-principles.. CDISC is financially supported by more than 250 biopharmaceutical, academic research, CRO, government, service and technology companies.. Among other things, CDISC proposes form/variable naming and list definition standards (look at the CDASH (Clinical Data Acquisition Standards Harmonization).. standard v1.. 1 of 2011/01/18.. ), which can be immediately applied when designing e-CRFs and study databases.. In addition to naming guidelines, CDISC also publishes recommendations.. A clear one on text fields is the following:.. “The general recommendation is that the.. collection of free text comments.. and general comments pages should be.. discouraged.. Collection of free text should be limited to cases of specific safety or therapeutic need in reporting or analysis, such as Adverse Events, Concomitant Medications or Medical History.. The.. recommendation.. is that questions be.. specific and clear.. rather than open-ended.. Instead of free text comment fields, it is recommended that a thorough review of the CRF by the protocol development team be performed to maximize the use of.. pre-defined lists of responses.. ”.. Next to CDASH, there are also the SDTM’s (Study Data Tabulation Model) and this was the subject of last week’s webinar.. Some of the standard SDTM domain classes are concomitant medication, study completion, adverse events, medical history and laboratory tests.. Important to note is that there s some overlapping between CDASH and SDTM.. Six new SDTM data submission domains were presented for key data shared by most (not all!) types of devices.. It is intended to guide the organization, structure and format of standard device clinical trial tabulation datasets submitted to regulatory authorities.. Because of the diverse medical use cases (imaging, implantables, diagnostics, …), this is a challenging project.. We joined this webinar as this is one of the most important working areas for e-novex.. CDISC - Study Data Tabulation Model (SDTM).. The new proposed SDTM device domains are:.. - Device information (DI).. - Device in-use (DU).. - Device exposure (DX).. - Device events (DE).. - Device tracking and Disposition (DT).. - Device-Subject Relationships (DR).. The DI SDTM holds, amongst other characteristics, trade name, model number, serial number, lot number, classification and expiration date.. An important update is how the data is to be stored.. The tabular model, as we know, has been replaced by a vertical structure (one record per characteristic), giving much more flexibility:.. - More metadata can be stored for each characteristic, still having a limited number of table fields.. - Characteristics can be added later on, without otherwise necessary table definition updates.. CDISC - Operational Data Model (ODM).. But there s more: CDISC is also the author of ODM (Operational Data Model, version 1.. 3), designed to facilitate the archive and interchange of metadata and data for clinical research.. In e-capture.. net we support both study definition (metadata) and data export (clinical data) in ODM v1.. 3 format.. As the number of device approvals (PMAs) by the FDA has increased by 52% in the past decade, and most submissions today are paper-based (although also SAS transport files can be submitted), the CDISC standardization seeks to develop collection and submission to support electronic submission of PMAs and other applications.. Nice effort hè (see.. ‘.. Bienvenue chez les Ch tis.. ’.. for a definition of hè).. And finally, check the upcoming CDISC webinars.. They are free of charge and could be very interesting depending on the domain you’re working in (e.. the webinar on 22-Sep-2011 is on ‘.. Biostatistics, What Every Clinical Data Manager Should Know.. ’).. New logo.. August 4, 2011.. The new e-capture.. net logo.. Following the launch of our new company website over at.. , you may have noticed that both the company and.. , the product, have the same logo.. This may be misleading in some cases, and we want to make a clear distinction between the company and the product, without alienating one from the other.. So we decided to create a new logo for.. that still uses the same colors as the company website.. You may have to refresh your browser before the new logo appears.. Let us know what you think about it in the comments!..

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  • Title: e-capture.net version 2.6 released | e-capture.net
    Descriptive info: This entry was posted in.. Bookmark the.. permalink.. One Comment.. Peter.. says:.. December 8, 2012 at 2:02 pm.. Decentralized user management, a very nice feature indeed!.. Reply.. Leave a Reply.. Cancel reply.. Your email address will not be published.. Required fields are marked.. *.. Email.. Website.. Comment.. You may use these.. HTML.. tags and attributes:.. a href= title= abbr title= acronym title= b blockquote cite= cite code del datetime= em i q cite= strike strong..

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  • Title: Stijn Van Loo | e-capture.net
    Descriptive info: Author Archives:.. 6, the latest installment of e-capture.. net, will be deployed to production at 5:00PM CET.. In the past we always released a new update every three months, but we have decided since then to decrease the number of releases per.. Continue reading.. It s been another three months since our latest release and we re excited to share with you what we have included in this release: Dashboard The homepage now displays a dashboard which provides a status overview of the different patients and.. A form.. 4 of our EDC platform e-capture.. Here s a short overview Layout changes The user interface of e-capture.. All.. 3 release of e-capture..  ...   production, and here s an overview of the most important features: Feedback messages Throughout the e-capture.. net application, we have started incorporating feedback messages.. We are featured on the new and improved EDC Market Tool that is available at http://edcmarket.. This is a.. As of November 14th 2011, e-novex has moved to a new office, along with our colleagues of genae.. Our new address is e-novex BVBA Justitiestraat 6B 2018 Antwerp BELGIUM We will also send out an official change of address e-mail.. Last week we held our annual staff meeting at e-novex right here in Antwerp.. One of the project managers at our sister company genae associates provided us with..

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  • Title: Releases | e-capture.net
    Descriptive info: Category Archives:.. 2 of the e-capture.. net EDC application will be released to production.. A lot of improvements and bugfixes have been implemented, and the most important ones are as follows: Automated password reset This has been a long-awaited feature.. Users.. 1 released.. June 8, 2011.. net v2.. 1 has been deployed to production.. This release marks an important step in the development lifecycle of the product.. Apart from some bugfixes, following important features have been added: Study selection When your user account has access to multiple..

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  • Title: Dive into SDTM | e-capture.net
    Descriptive info: 6 released..

    Original link path: /blog/2012/09/dive-into-sdtm/
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  • Title: Michael Golichenko | e-capture.net
    Descriptive info: This training consisted of: A detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design A discussion.. DevExpress upgrade to 11.. July 19, 2011.. Ever since it s inception, e-capture.. net has relied on the third-party components of DevExpress, to build a flexible and customizable UI for our end-users.. Although at first the learning curve is quite steep, the DevExpress components are stable and easy to..

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  • Title: CDISC and Medical Devices | e-capture.net
    Descriptive info: Study documents on frontpage..

    Original link path: /blog/2011/08/cdisc-and-medical-devices/
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