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Jean-Marc Bobée Doctor of Pharmacy

Anti-counterfeiting Technological Strategies How technology can help to fight counterfeits and improve patient safety ? International Symposium European Logistics Mediterranean 17 June 2016 – Montpellier. Jean-Marc Bobée Doctor of Pharmacy

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Jean-Marc Bobée Doctor of Pharmacy

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  1. Anti-counterfeiting Technological StrategiesHow technology can help to fight counterfeits and improve patient safety ?International Symposium EuropeanLogisticsMediterranean17 June 2016 – Montpellier Jean-Marc Bobée Doctor of Pharmacy Director Anti-counterfeiting Strategy Sanofi, Industrial Affairs JM Bobée – 17 Juin 2016

  2. Content • Introduction: scope • Counterfeits in Pharmaceutical Industry • How technology can help fighting counterfeits Key technological anti-counterfeiting principles : • Packaging Tamper evidence • Authentication technologies • Identification Technologies • Global Traceability concept based on serialized Data Matrix • Serialization of secondary packs only (Europe-efpia concept) • Serialization and aggregation of all logistic units (Turkey-USA) • Local Traceability concepts (specificities) • China - Nigeria • Conclusion JM Bobée – 17 Juin 2016

  3. Counterfeiting: a worldwide public health issue (1) IMPACT, Counterfeit Drugs Kill!, World Health Organization, Geneva, 2008 (2) WHO (December 2011). (3) Report on UE customs enforcement of intellectual property rights 2011. (4) INTERPOL, 2015. (5) IRACM, 2014. (6)Nayyar, GML et. al., Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa, 2012. (7) InstitutoBrasileiro de éticaconcorrencial. Contra pirataria, , remédios vão ganhar seu próprio ‘RG’, 2012. JM Bobée – 17 Juin 2016

  4. Scope/Problematics Counterfeit Example : Novalgina in Peru • Could you tell which pack is counterfeit ? How Technology can help to fight Counterfeits ? JM Bobée – 17 Juin 2016

  5. What are the possible responses against counterfeits ? Intense cooperation with Authorities(Health agencies, Customs, Police..)and international organisms(WHO, Interpol, PSI…) An internal organisation fully dedicated to fight counterfeitsSecurity, Corporate/Affiliates Central Anti-counterfeit Laboratory … Regular controls Market Surveillance (+ internet) … Which actions to fight counterfeits efficiently ? A systematic treatment of all suspiscious cases=> Investigations and legal actions A strong communication effort Press , Authorities, Patients, Health professionals, Politics … An efficient technological prevention JM Bobée – 17 Juin 2016

  6. 3 Key Principles for an efficient Technological Anti-Counterfeiting Strategy Increased Protection (Patient/Product) Harmonised identification of secondary packs of pharmaceuticals (Mass serialization + control at unit level) Product Identification ProductAuthentication Use of Overt and Covert features to authenticate products Product Integrity Guarantee the integrity of manufacturer’s pack throughout the entire supply chain JM Bobée – 17 Juin 2016

  7. Principle n°1 : Pack Integrity Increased Protection (Patient/Product) Harmonised identification of secondary packs of pharmaceuticals (Mass serialization + control at unit level) Product Identification ProductAuthentication Use of overt and covert features to authenticate products Product Integrity Guarantee the integrity of the manufacturer’s pack throughout the entire supply chain JM Bobée – 17 Juin 2016

  8. Tamper Evidence Technologies for secondary packagings • Guarantee the integrity of the original manufacturer’s pack throughout the entire supply chain • Packaging tamper evidence for all products (seal, perforated cartons + glue) • => Alerts on the opening of the product • => guarantee integrity of packaging content Folding Box with tamper evident seal or security seals Folding Box with pre-cut carton + glue JM Bobée – 17 Juin 2016

  9. Principle n°2 : Pack Authentication Increased Protection (Patient/Product) Harmonised identification of secondary packs of pharmaceuticals (Mass serialization + control at unit level) Product Identification ProductAuthentication Use of overt and covert features to authenticate products Product Integrity Guarantee the integrity of the manufacturer’s pack throughout the entire supply chain JM Bobée – 17 Juin 2016

  10. Overt & Covert security features to authenticate products • Overt => Authentication by the supply chain(wholesalers, pharmacies, hospitals…) Ex : Holograms Colour shifting inks/Films guilloches… • Covert => Authentication by the manufacturer (chemical signature)… Ex : Taggants • Technology choice should be specific to each manufacturer (in order to reduce risk of copy and to adapt to company organisation & equipments) • Technologies to be used for high risk products (mostly secondary packaging) • Issue = repackaging practices JM Bobée – 17 Juin 2016

  11. Sanofi Security LabelExample : Plavix Protection JM Bobée – 17 Juin 2016

  12. Principle n°3 Pack Identification/Serialization Global Concept (Verification by Supply Chain) Increased Protection (Patient/Product) GTIN/NTIN: 12345678901234 Batch: A1C2E3G4I5 Expiry: 07-2015 Ser Num 1234567890 1234567890 Harmonised identification of secondary packs of pharmaceuticals (Mass serialization + control at unit level) Product Identification Local Concept (Verification by Patient - MAS) ProductAuthentication Use of overt and covert features to authenticate products Product Integrity Guarantee the integrity of the manufacturer’s pack throughout the entire supply chain JM Bobée – 17 Juin 2016

  13. Global ConceptTraceability evolution based on Harmonized/standardized identification system using Data Matrix Code & Mass Serialization • Traceability today : • At batch level • Linear barcode including product code read automatically with a barcode reader at pharmacy level (not in all countries) • Batch number and expiry date (variable mentions) written in clear on the secondary and primary packaging • No interoperability of the existing systems • Traceability tomorrow : • At unit of sales level (i.e. at box level) • Product code, batch number and expiry date will need to be included in the Data Matrix code in order to be read automatically and avoid dispensing errors (already available in France &Turkey) • Automatic detection of expired products/facilitate batch recall • Deliver the right product to the right patient • Serialization (1 randomized number per box) would allow to • Prevent counterfeits • Fight reimbursement fraud • A unique standard with high level security for all patients JM Bobée – 17 Juin 2016

  14. Overview of the different traceability regulations (per country) Global concept (serialized Data Matrix) versus local concepts (China, Nigeria) Egypt (tbc) Brazil (Under revision) Taiwan (tbc) China South Korea United States Europe Ukraine Saudi Arabia Argentina Turkey PAKISTAN Jordan Russia India (N/A) Nigeria Data Matrix ECC 200 Dec 2016 : Serialization & Aggregation for 1 product/3 lots/legal entity(Pilot) End 2018 (date to be confirmed): Extension to all medicines Data Matrix ECC 200 July 2017-2018: GTIN, GLN,artworks, data July 2018: Serialization of all Medicines July 2019: Aggregation of all logistic units and reporting to a central govnt database Data Matrix ECC 200 July2017: Non serialized Data Matrix Jan 2019: Serialization for all Medicines March 2015: Non Serialized Data Matrix ECC 200 Mar 2017: Serialized Datamatrix (Aggregation + reporting tbc later on) Data Matrix ECC 200 2017 (tbc): Serialization for all Medicines (tbc) Data Matrix ECC 200 Date TBC: Serialization and aggregation for all Medicines (tbc) Data Matrix ECC 200 +Tamper evidence Since 2011: progressive implementation of Serialization & Aggregation (required by wholesalers) with no verification at point of dispense ( => from high risk products to all prescription medicines) Data Matrix ECC 200 Serialization (+ Aggregation) for all registered Medicines Jan 2015: 30% products Dec 2015: 100% of products July 2017:-july 2018 / Non Serialized Data Matrix Jan 2020 (tbc): Seria-lization only with State/ MoH (JFDA) Database Data Matrix ECC 200 (tbc) Serialization + Aggregation Jan 2017: Special drugs Jan 2018 : Essential Drugs Jan 2019: other Drugs Linear barcode Since 2011: Serialization & Aggregation (at case level only) with no verification at dispensing point for EDL products only End 2015: all products Data Matrix ECC 200 Since Jan 2012: Serialization & Aggregation + Verification at all levels of the supply chain (including point of dispense) for all prescription medicines Data Matrix ECC 200 + Tamper evidence Feb 2019 (according to Delegated Acts) Serialization only + Verification at point of dispense for all countries except Belgium, Italy and Greece (Feb 2025) Data Matrix ECC 200 + Tamper evidence Congress Bill signed in November 2013 which pre-empt previous california Law Jan 2015: traceability at batch level within all the supply chain Nov 2017 (4 years after enactment): Serialization of Packs & homogeneous cases Nov 2023 (10 years after enactment): Traceability at unit level (pack) required with control system to be defined by stakeholders after pilots studies Data Matrix ECC 200 +Tamper evidence when serialized Non serialized datamatrix for Governments tenders April 2016: Serialization & Aggregation for exported drugs to countries with no serialization regulation Local Serialization + possible verification by patients Mobile Authentication System (serialized scratch label) for Anti-malarials (Jan 2013) & Antibiotics (March 2013) JM Bobée – 17 Juin 2016

  15. Global concept : 2 Traceability scenarios “Serialization only” or “Serialization + Aggregation” “Serialization only” = serialization of secondary packaging • With a serialized data matrix: unique identifier (product code & serial number) • In association when possible with systematic control at point of dispense (patient security) “Serialization & Aggregation”: Serialization of all logistic units including hierarchy of all serial numbers (between packs, bundles, cases and pallets) • Allow possibility to record products flow or locate a specific pack in the supply chain (Track & Trace) Pack • Serialization only Bundle1 Serialization & Aggregation Case Pallet 1 Optional and depending on regulation with Data Carrier to use. JM Bobée – 17 Juin 2016

  16. Next Priorities: • India - Russia • Saudi Arabia • Brazil TRACEABILITY REGULATIONS REQUIREMENTS: Overview of human health regulations The key driver of the Serialization Program is the traceability regulation (country by country) • Patient Safety (batch recall, disp. errors & counterfeits prevention) • Fight tax & reimbursement fraud Serialization (+/- Aggregation) based on Data Matrix(ECC200) Saudi Arabia March2017     Ukraine Europe Feb2019 Egypt (tbc) Jordan 2018/2020 Turkey 2010 Argentina 2011-2014 China 2011-2015 South Korea 2015 India 2016 Brazil* 2016-2018 Russia 2017-2019 US Nov2017 Target dates Taiwan (tbc) Serialization (+ 100% reconciliation ?) Serialization & Aggregation For special products Serialization & Aggregation (100% reconciliation) Progressive plan Jan 2015: 30% of products Dec 2015: 100% of products Serialization & Aggregation (DM) printed directly on pack (Delayed) 2018 / Non Serialized DM 2020 /seria-lization (+ 100% reconciliation ?) Serialization (2018) & Aggregation (2019) Regulation highlights Non Serialized DM (July2017) Serialization (Jan 2019) Serialization High risk products for all countries (except BE, IT & GR Feb 2025 at the latest) • Jan 2010: DM Serialization • Jan 2012 : Aggregation Serialization & Aggregation Special products in 2011 and all medicines in 2015 Serialization & Aggregation of all exported medicines + Comply with existing countries regulations Serialization & Aggregation Critical drug in 2017, Vital drug in 2018 and all medicines in 2019 Serialization of Packs & cases (+ aggregation before 01/2023) Packs Tamper Evidence required when serialized * new proposal : Pilot in 2016 & full implementation within 3 years after new law publication (tbc) JM Bobée – 17 Juin 2016

  17. Scenario 1 “Serialization only” with systematic control at dispensing point (“end-to-end” system) - European Concept GTIN/NTIN: 12345678901231 Batch: A1C2E3G4I5 Expiry: 07-2008 Ser Num 1234567890 1234567890 • Systematic verification of serialized Data Matrix (ECC200) at point of dispense => efficient to protect patients from counterfeits and to fight reimbursement fraud (by detecting duplicate serial numbers) • Much more simple and less costly to implement for pharma companies than full Track & Trace • No aggregation (between logistic units) required by manufacturers => reduce investments by at least 2 (no serialization of bundles, cases and pallets) • No impact on Manufacturers and Wholesalers Distribution Centers (no systematic control at unit level ) • However does not provide the SN of the packs contained in a case or a pallet • Needs investments at pharmacy level for Data Matrix reading and data verification • Very High “Security/Cost” ratio => The most cost effective solution when possible JM Bobée – 17 Juin 2016

  18. Industrial Impact :Serialization of secondary packs by printing a Data Matrix directly on line • Serial Number included in a Datamatrix ECC 200 printed directly on the packIn addition to the product traceability information : • Product code • Batch number • Expiry date GTIN/NTIN: (01) 07046261398572 Batch: (10) TEST5632 Expiry: (17) 221018 S/N: (21) 12345678901234567890 Unique Identifier = Product code + Serial Number JM Bobée – 17 Juin 2016

  19. Example of Specific Equipment for Serialization on line Integrated HMI with keyboard Serialization software + vision control + printing control Printing equipment (cartridges) + Vision equipment (camera + lighting system) Ejection Module 2D barcode (Datamatrix) reader (for decommisioning) JM Bobée – 17 Juin 2016

  20. Equipment for packs serialization on packaging line Datamatrix visible on screen JM Bobée – 17 Juin 2016

  21. Serialization of packs Then packaging in cases and Pallets JM Bobée – 17 Juin 2016

  22. PharmaceuticalManufacturer ParallelDistributor European Hub Architecture Interoperability between national databases is key to secure products flow in Europe (repackaging) EuropeanHub NationalBlueprintSystem 1 NationalSystem 1 NationalBlueprintSystem n (Germany) NationalSystem n Pharmacy Wholesaler Pharmacy Wholesaler Wholesaler Wholesaler Pharmacy Pharmacy Parallel Distributor: mandatory verification + data upload Manufacturer: data upload + voluntary verification Periodic cross-region update Pharmacy: mandatory verification JM Bobée – 17 Juin 2016 Wholesaler: voluntary verification

  23. => Lower “Security/Costs” ratio : due to the higher level of investments and running costs, increased process complexity and loss of productivity for stakeholders Scenario 2“Serialization & Aggregation” of all logistic units with systematic control at different levels of the supply chain • Highly complex and more costly and difficult to implement • Aggregation between logistic units required for manufacturers (and for wholesalers when they change original hierarchy) • Systematic control to be made by manufacturers and wholesalers in their Distribution Centers => Higher investments for all and loss of productivity (OEE) for manufacturers (impact on packaging lines) and wholesalers (impact on Distribution Centers) • Benefit = Possibility to track back (or to locate) a specific pack (=> Distribution history at pack level) • Limited added value in terms of patient security (compared to end to end concept when possible) but comparatively allow products visibility in the supply chain JM Bobée – 17 Juin 2016

  24. Example of Scenario 2 : Turkey (Jan 2012)Serialization/aggregation with systematic control at all level of the supply chain JM Bobée – 17 Juin 2016

  25. Industrial Impact Serialization and Aggregation process onpackaging line (Packs => cases => Pallets) JM Bobée – 17 Juin 2016

  26. Industrial impact on Distribution Center activities for managing re-aggregation of logistic units (cases in pallets for ex) JM Bobée – 17 Juin 2016

  27. Turkish Pharmaceutical Track & Trace System How does it work? Wholesaler Physical transfer 1 3 Production notification Manufacturer sale notification(receive) Manufacturer 2 Manufacturer Sale notification(send) Reception notification 4 Wholesaler sale notification(send) 5 Physical transfer ITS/PTS Wholsaler sale notification(receive) 6 Payment 10 Reception notification 7 Reimbursement assosiation Dispensing notification 8 Delivery information 9 Pharmacy JM Bobée – 17 Juin 2016

  28. Sale Sale Sale Wholesaler 2 Wholesaler 1 Retail Pharmacy Patient USA Traceability Regulation • Dec 2017 : serialization of seconday packs and homegeneous case (no aggregation) • Dec 2023 : Full Track & Trace at pack level (aggregation) + control system to be defined by Stakeholders after pilot studies • Industrial Impact : Bottle Aggregation • Control system : Pedigree concept or control at point of dispense ? MARRIAGE DUMMY CODE SGTIN CODE IS ASSOCIATED WITH THE DUMMY CODE AGGREGATION IS DONE READING THE DUMMY CODES BOTTLES ARE AGGREGATED 2D CODE Manufacturer JM Bobée – 17 Juin 2016

  29. Local ConceptNon harmonized identification system (Specificities) • Local Exceptions to the global concept => specificities • Based on serialization only (No other traceability information data included in the code) • For historical reasons (fight against reimbursement fraud) • Italy (Bollino) = linear barcode (printed by Government) • Belgium = linear barcode (printed by Manufacturers) • Greece = linear barcode (printed by Manufacturers) • Due to local specificities • China = linear barcode (since 2011 for special drugs/Government) • Nigeria = Pin code printed on a scratch label (2013 for all anti-infective drugs/Manufacturers) • No interoperability of the existing systems • Should be transitory situations before moving to the global serialized Data Matrix system in future (Problem for Africa because MAS allows patients to control their products in both legal and illegal supply chains) Bollino (Italy) Already in place) China : Linear Barcode printed (or pre-printed by artwork printer) on the carton of the pack (2011) Africa/Nigeria Pin code (12 digits) printed on a scratch label JM Bobée – 17 Juin 2016

  30. China specific serialization system(mandatory since 2011 for all Essential Drugs List products mandatory for all pharmaceuticals end 2015) • Unique 20 digit Serial Numbers provided by Chinese SFDA (for packs and cases) • Linear Barcode 128 (called E-Code) printed on the pack (usually pre-printed by artwork printer) • Linear Barcode read on the packaging line and activation of the Serial Number in the manufacturer data base • Aggregation on line (between packs and cases) and printing E-code on the labels of the cases • Transfer of the activated Serial Numbers & Hierarchy to the Chinese SFDA data base The goal is to verify the pack serial number, identify the product batch and manufacturer by scanning the unique E-Code of the pack at any point in the supply chain. Database should also provide the pack owners since it was produced Not mandatory on bundles Not mandatory on pallets JM Bobée – 17 Juin 2016

  31. Another recent example of specific local serialization concept The Mobile Authentication System (MAS) in Nigeria Control of PIN CODE is done by the patient with his mobile phone (send & receive SMS) = Mobile Authentication system - MAS system (Nigeria) No systematic control in the supply chain (not liable or under-developed) Significant cost for the manufacturer to serialize his products (manufacture Labels, transport & apply labels , read & activate labels in relation with the product ; transmission of serial numbers to the central database of the system) Only 5 to 10% of the patients are controlling the serial number of their medicine in Nigeria => MAS is not a 100% liable solution but however can save human lives (when serial number does not exist in the database, identification of duplicates,. ..) => Low Ratio “Security/Costs” due to the low level of security (limited number of controls) and to the high cost and complexity of the labelling process |31 JM Bobée – 17 Juin 2016

  32. How serialization can efficiently secure medicines and patients ?The 3 types of controls associated with Mass Serialization • Efficiency of Serialization and patient protection depend on the capability to control the product information contained in the Data Matrix before dispense (ie products codes & Serial Numbers) • Serialisation is not enough - Control is essential ! • Costs & Complexity vary according to the different level of controls implemented (with different “Benefit/cost” ratios) Serialization + Systematic Control at different levels of the supply chain => Aggregation of logistic units (Turkey, China, Brazil, California) Increased Cost and Complexity to implement Serialization + Systematic Control at Dispensing Point (ESM/Efpia/Europe) Serialization + Statistical control post delivery No Systematic Control => (Italy, Greece, Belgium, Nigeria) JM Bobée – 17 Juin 2016

  33. Evaluation of the 3 types of controls associated with Mass Serialization in terms of “Benefit/Cost” • Serialization and “End to End” verification concept provides the best “Benefit/Cost” ratio (when control at dispensing point is possible) => Preferred option when possible • Full Track and Trace is more complex and very expensive to implement Serialization + Systematic Control at Dispensing Point (ESM/Efpia/Europe) “Benefit/Cost” ratio (considering product and patient security) Serialization + Systematic Control at different levels of the supply chain => Aggregation of logistic units (Turkey, China, Brazil, California) Serialization + Statistical control post delivery No Systematic Control => (Italy, Greece, Belgium, Nigeria) JM Bobée – 17 Juin 2016

  34. Conclusion • Global ACF strategy based on association of several technologies (Pyramid) • Tamper evidenceof the secondary packaging is essential • Authentication technologies(covert and overt, specific to each company) for protection of high risk products • Mass serialization + Control at unit level (Control is essential to secure patients !) • Global concept for mature supply chain using open standards and Data Matrix code (ECC200) in associationwith “systematic control at the dispensing point”=>provides the best “Benefits/cost” ratio to secure patients • By exception, local concept for unsecured supply chain using non standard pre-serialized scratch label + MAS with (non systematic) verification by patients => Africa where global concept can not yet apply • Use of information/communication technologies is important (in both cases) • 2 Key challenges to address in the future: • Traceability and security of pharmaceutical products sold byinternet/web • Web-sites certification ? • Security and control of medicines distributed in developing countries • Development of a secure official supply chain • Affordable traceability systems : How to replace MAS technology by Serialized Data Matrix in Africa ? JM Bobée – 17 Juin 2016

  35. Thank you JM Bobée – 17 Juin 2016

  36. Back Up Slides JM Bobée – 17 Juin 2016

  37. Counterfeiting: a worldwideAnd growingpublic healthissue JM Bobée – 17 Juin 2016

  38. What is Datamatrix (ECC 200) ? • Datamatrix symbol is a matrix of black and white points representing respectively 1 or 0 • Matrix can be square or rectangular • Data are encoded in bytes and several additional bytes are added (redundancy) for errors detection and errors correction (in case of damage for example) (01) 3400930000122 (10) n°de lot (17) AAMMJJ JM Bobée – 17 Juin 2016

  39. Why Data Matrix ECC200 ? • Data Matrix is a EAN.UCC (GS 1) standard since July 2004 • Data Matrix is using international syntax EAN.UCC (GS1) 128 • Data Matrix is the smallest symbol for a given quantity of information • Data Matrix is robust : the Reed Solomon error correction system allow Data matrix reading even with a high level of code damage (information redundancy) • Data Matrix can be printed with technologies currently used in Pharmacy (Inkjet, laser, Drop on Demand, thermal transfer) • Data Matrix is cost competitive(0.1 to 0.3 cents of €) • Data Matrix is used successfully by IFAH for coding all animal health products worldwide • Data matrix is mandatory in France since 01/01/11 for each pharmaceutical packaging (product code + batch n°+ expiry date) • Data Matrix is the code proposed by all Stakeholders for identification of medicines packs in Europe (in relation with Falsified Medicines Directive implementation) JM Bobée – 17 Juin 2016

  40. Definitions JM Bobée – 17 Juin 2016

  41. Definitions (1) • TRACEABILITY = possibility to follow a product at different levels from manufacturing to dispensing point • WHOLESALER = intermediate who acts in the medicine’s supply chain between the manufacturer and the dispenser • Full lines wholesalers buy medicines in big quantities to manufacturers and sell them to pharmacies • Secondary wholesalers usually buy medicines from other wholesalers and sell them to other wholesalers or to pharmacies • DISPENSING POINT = location where the medicines are sold/dispensed (mainly pharmacies or hospitals) JM Bobée – 17 Juin 2016

  42. Definitions (2) • TAMPER EVIDENCE = packaging feature or design allowing visible evidence/recognition by the supply chain or by the patients when the packaging has been open (=> packaging destruction) • Ex : Precut carton box or Tear away strip + Glue (for secondary packaging) • Ex : Aluminium blisters (for primary packaging) • AUTHENTICATION = control operation based on the recognition of overt and covert authentication features providing the guarantee that the product is genuine • Use of holograms, colour shifting inks or taggants for example • IDENTIFICATION = characterisation/control operation based on the recognition of a readable code attributed to each product by the manufacturer and containing key informations about the product • Ex : datamatrix code including product code, batch number, expiry date and serial number • Identification technologies (codes) do not usually provide the guarantee that the product is genuine (by opposition to authentication technologies) JM Bobée – 17 Juin 2016

  43. Definitions (3) • COUNTERFEIT DRUGS are deliberately and fraudulentlymislabeled with respect to identity and/or source. May include drugs with the correct or incorrect ingredients, insufficient or no active ingredients, or with fake packaging • DIVERTED DRUGS are ethical drugs purchased in low price markets, sometimes repackaged, and diverted to other markets by means of a distribution system not authorized by the manufacturer. This type of activity creates what are often referred to as Grey Markets or Parallel Markets JM Bobée – 17 Juin 2016

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