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The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. You will not disclose any of the information to others without written authorization from \u0013 MACROBUTTON EmptyMacro [Insert Sponsor Name Here]\u0015, except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered.\nThe sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential document for the sole information and use of the investigator's team and the IRB/IEC. Example language below:\n\u000f\nSYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE\nEdition Number\nInsert synopsis of changes since previous version.  If none, delete this page.  If you do not include this synopsis of changes when updating your Investigator’s Brochure, it is recommended that you provide a tracked version to investigators to facilitate their review of changes.\n\u000f\nTABLE OF CONTENTS\n\u0003\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc101777338\" \u0014CONFIDENTIALITY STATEMENT\t\u0013 PAGEREF _Toc101777338 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777339\" \u0014SYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE\t\u0013 PAGEREF _Toc101777339 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777340\" \u00141.\tTABLE OF CONTENTS\t\u0013 PAGEREF _Toc101777340 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777341\" \u00142.\tSUMMARY\t\u0013 PAGEREF _Toc101777341 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777342\" \u00143.\tINTRODUCTION\t\u0013 PAGEREF _Toc101777342 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777343\" \u00143.1\tName(s) of Drug Product\t\u0013 PAGEREF _Toc101777343 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777344\" \u00143.2\tActive Ingredients\t\u0013 PAGEREF _Toc101777344 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777345\" \u00143.3\tPharmacological Class\t\u0013 PAGEREF _Toc101777345 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777346\" \u00143.4\tRationale for Performing Research with the Investigational Product\t\u0013 PAGEREF _Toc101777346 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777347\" \u00143.5\tProposed Indication(s)\t\u0013 PAGEREF _Toc101777347 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777348\" \u00143.6\tGeneral Approach for Evaluating the Investigational Product.\t\u0013 PAGEREF _Toc101777348 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777349\" \u00144.\tPHYSICAL, CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATION\t\u0013 PAGEREF _Toc101777349 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777350\" \u00144.1\tPhysical, Chemical, and Pharmaceutical Properties\t\u0013 PAGEREF _Toc101777350 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777351\" \u00144.2\tDescription of Drug Substances and Formulation\t\u0013 PAGEREF _Toc101777351 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777352\" \u00144.3\tStorage and Handling\t\u0013 PAGEREF _Toc101777352 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777353\" \u00145.\tNONCLINICAL STUDIES\t\u0013 PAGEREF _Toc101777353 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777354\" \u00145.1\tIntroduction\t\u0013 PAGEREF _Toc101777354 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777355\" \u00145.2\tNon Clinical Pharmacology\t\u0013 PAGEREF _Toc101777355 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777356\" \u00145.3\tPharmacokinetics and Product Metabolism in Animals\t\u0013 PAGEREF _Toc101777356 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777357\" \u00145.4\tToxicology\t\u0013 PAGEREF _Toc101777357 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777358\" \u00146.\tEFFECTS IN HUMANS\t\u0013 PAGEREF _Toc101777358 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc101777359\" \u00146.1\tIntroduction\t\u0013 PAGEREF _Toc10177","cbCaipIZqiCAlLsq","https://ap.wps.com/l/cbCaipIZqiCAlLsq","docx",36241,13,"English","# CONFIDENTIALITY STATEMENT\n## SYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE\n## TABLE OF CONTENTS\n## 1. TABLE OF CONTENTS\n## 2. SUMMARY\n## 3. INTRODUCTION\n## 3.1 Name(s) of Drug Product\n## 3.2 Active Ingredients\n## 3.3 Pharmacological Class\n## 3.4 Rationale for Performing Research with the Investigational Product\n## 3.5 Proposed Indication(s)\n## 3.6 General Approach for Evaluating the Investigational Product\n## 4. 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