Protocol Number 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:
Initial Number has the meaning set forth in Section 13(B).
Data Universal Numbering System (DUNS) number means the 9-digit number assigned by Dun and Bradstreet, Inc. (D&B) to identify unique business entities.
Data Universal Numbering System +4 (DUNS+4) number means the DUNS number assigned by D&B plus a 4- character suffix that may be assigned by a business concern. (D&B has no affiliation with this 4-character suffix.) This 4-character suffix may be assigned at the discretion of the business concern to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts for the same parent concern.
Data Universal Numbering System+4 (DUNS+4) number means the DUNS number means the number assigned by D&B plus a 4-character suffix that may be assigned by a business concern. (D&B has no affiliation with this 4-character suffix.) This 4- character suffix may be assigned at the discretion of the business concern to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts (see the FAR at Subpart 32.11) for the same concern.
Serial number means a vehicle identification number that is affixed to a part of a motor vehicle and that is:
Identifying number means a symbol or address that identifies only one unit in a common interest community.
Data Universal Number System (DUNS) Number means the 9-digit number assigned by Dun and Bradstreet, Inc. (D&B) to identify unique business entities.
Serial number within the part, lot, or batch number means a combination of numbers or letters assigned by the enterprise to an item that provides for the differentiation of that item from any other like item within a part, lot, or batch number assignment.
Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.
Index Number means the Consumer Price Index (Sydney all groups) published by the Australian Bureau of Statistics from time to time.
Positive identification means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:
Item number means the unique number attached to each professional service contained in the Medicare Benefits Schedule (MBS). Each item number has a set benefit. For more information see MBS Online.
Fax Number Email Address: Credentialing Contact: Telephone Number: Fax Number: Email Address:
Lot or batch number means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.
DUNS Number means a unique nine digit identification number provided by Dun & Bradstreet for each physical location of Grantee’s organization. Assignment of a DUNS Number is mandatory for all organizations seeking an Award from the state of Illinois.
Accredited school means a school that is accredited by an accrediting agency, recognized according to Minn. Stat. § 123B.445 or recognized by the Commissioner of the Minnesota Department of Education (MDE).
voter ID number means a unique, randomly generated numeric identifier allocated to each voter by the Returning Officer for the purpose of e-voting,
Serial number within the enterprise identifier means a combination of numbers, letters, or symbols assigned by the enterprise to an item that provides for the differentiation of that item from any other like and unlike item and is never used again within the enterprise.
Winning Numbers means the game results selected during a Drawing which shall be used to determine winning Plays contained on game ticket or ticketless transaction.
CAS number means the Chemical Abstract Service registry number identifying a particular substance.
CT number means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.
Lot number or “batch number” means a distinctive group of numbers, letters, or symbols or any combination of these that is unique to a group of cannabis goods.
Total Number of Directors means the total number of directors comprising the Board from time to time.
Gender means actual or perceived sex and shall include a person’s gender identity or expression.
Listing Statement means the listing statement of Purchaser pertaining to the Transaction and in the form prescribed by the CSE;