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Study drug and comparator Chart 1. Product description

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Study drug and comparator Chart 1. Product description

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  1. Open-label, randomized, multicenter, comparative clinical trial to estimate efficacy and safety of Kanarb (fimasartan), tablets 60/120 mg, manufactured by BoriungFarmaceutical Co. Ltd, Korea, and Kozaar (lozartan), tablets 50/100 mg, manufactured by Merck Sharp and Doum B. V., the Netherlands, in adult patients with Grade I-II arterial hypertension Protocol№ СС09042014 Moscow, 24th March 2014

  2. Study drug and comparator Chart1. Product description

  3. List of study sites Chart2. Study sites per protocol СС09042014

  4. List of study sites

  5. Communicational Chart Cromos -vCorex Vladlena Baranovskaya, project manager, Cromos Iliya Chistyakov, CRA, Cromos Natlia Stepanchenko, CRA, Cromos Depot-ops@corex-depot.com Delivery service Investigational sites IliyaKurdumov, head of warehouse, Corex Vera Balakireva, Quality director, Corex support@corex-depot.com Corex management

  6. Receipt of study drugs atCorex Depot • After the preparation for shipment Cromos sends a notification to email: depot-ops@corex-depot.com containing following information: product name, quantity, date of shipment, etc. • Corex organizes the delivery of study drugs from R-pharm warehouse to Corex Depot. Courier services are provided by Courier Service Express (CSE) • Study product are transported under t°=15-25°С with the use of thermal containers TM35 and temperature loggers • Corexrecieves study drugs under standard procedure and issues Receipt Note (RN) • RN should be signed by warehouse specialist, Alina Grankina, and qualified person, IliyaKurdumov • Copy of signed RNshould be sent to Vladlena Baranovsakya by email vladlena.baranovskaya@cromospharma.com

  7. Receipt of study products to Corex depot Pic. 1. Sample of RN

  8. Storage of study drugs • Study products should be stored at ambient temperature (t°=15-25°С)in special area away from heat, moisture, and light

  9. Additional Labelling • Additional labeling should be done by following steps: • Cromos should approve label design • Cromosshould approve the size of labels and place for labeling • Corex should make stickers/labels according to the above mentioned steps. Responsible person is Alina Grankina • Corex places stickers/labels on the study drug packaging • Corex issues documental form for additional labelling and sends a copy of the form to Cromos by email vladlena.baranovskaya@cromospharma.com

  10. Dispatch of study drugs from Corex to sites • Cromos sends a request for dispatch to email depot-ops@corex-depot.com with the following information: protocol number, site number, description and quantity of study product, estimated date of arrival • Request is processed within 1 day; after that Corex organizes the dispatch (from Monday till Wednesday). To avoid deviation of temperature conditions, there will be no dispatches on Thursdays or Fridays. • Study drugs areshipped with the use of thermo boxes TM35 and temperature loggers • For each delivery, Corex issues Dispatch note(DN) (2 copies attached to delivery) • Recipient at site checks temperature logger (alarm /not alarm), study drugs delivered (name, quantity, batches, etc.) and signs and dates both copies of DN • One copy of signed DN should be sent by fax +7 (499) 647-59-42or email depot-ops@corex-depot.com to Corex depot • Received copy of DN confirms that study drug is delivered by Corex to site

  11. Dispatch of study products from Corex to sites • Pic. 2. Sample of Dispatch Note

  12. Return and destruction of unused materials • Cromos should send requests for the return or the destruction to email depot-ops@corex-depot.com containing the following information: protocol number, site number, description and quantity of the product, estimated date of the dispatch • Corex should organize courier shipment of study drug from sites to Corexdepot • Corex should place returned materials in the relevant storage area: returned drug is stored with temperature-control , drugs for destruction - without temperature-control • Corex issues the following documents for these procedures: 1) MedicinalProductsReturnNote 2) Destruction Note

  13. Contacts • Corex: • Address: 1, ul. Komsomolskaya, 142 100, Podolsk, Russia • Phone: +7 (499) 647-59-41, Fax:+7 (499) 647-59-42 • URL: www.corex-depot.com • IliyaKurdumov, head of warehouse, +7 (916) 400 8899, ikurdyumov@corex-depot.com • Alina Grankina,warehouse specialist, +7 (967) 294 4307, agrankina@corex-depot.com • Vera balakireva, Quality director, + 7 (926) 071 2644,vbalakireva@corex-depot.com • Cromos: • Vladlena Baranovskaya, project manager +7 (925) 092 1209, vladlena.baranovskaya@cromospharma.com • Iliya Chistyakov, CRA, +7 (926) 114 01 70, ilya.chistyakov@cromospharma.com • Natalia Stepanchenko, CRA, +7 (926) 246 6308, e-mail: natalia.stepanchenko@cromospharma.com • Corex support: support@corex-depot.com

  14. Customer support Besides directcontactwiththeteam, you may take advantage ofcustomer’ssupportservice. Inanysituation, orincaseofemergency, pleasesendyourquestionsorsuggestionstothe email: support@corex-depot.com 24 / 7. Ourmanagerswillreceiveinformationaboutthecaseandwillreactaccordingly. Informationletteraboutthisservicewillbeattachedtoeachshipmentsothatrecipientsmightbeinformedaboutcustomers’ servicesupportofCorex.

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