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Acceptance of this document constitutes agreement by the recipient that no information contained herein will be published or disclosed without prior written authorization from an official of Trevi Therapeutics, Inc. However, this document may be disclosed to appropriate Institutional Review Board and Ethics Committees or duly authorized representatives of a national regulatory authority under the condition that they are requested to keep it confidential. In the event of an actual or suspected breach of this obligation, Syneos Health should be notified promptly.  \nRevision History  \n\n| Version \\# | Date\u003Cbr>(dd-mmm-yyyy) | Document Owner | Revision Summary |\n| --- | --- | --- | --- |\n| Draft Version 0.3 | 17Jul2018 | Philippa Rook | Initial release version – draft version 0.3 |\n| Draft Version 1.0 | 14Aug2018 | Philippa Rook | Updated draft version 1.0 |\n| Final Version 1.0 | 24Aug2018 | Philippa Rook | Final version 1.0 |\n| Final Version 1.1 | 08Aug2019 | Philippa Rook | Updated Final version 1.1 for the removal of Part B |\n\nI confirm that I have reviewed this document and agree with the content.  \n\n| APPROVALS |  |  |\n| --- | --- | --- |\n| Syneos Health |  |  |\n|  |  |  |\n| Lead Biostatistician\u003Cbr>Philippa Rook\u003Cbr>Biostatistician II |  Date (dd-Mmm-yyyy) |  |\n| Senior Reviewing Biostatistician\u003Cbr>Georgia Gourgioti\u003Cbr>Manager, Biostatistics |  Date (dd-Mmm-yyyy) |  |\n| Lead Statistical Programmer\u003Cbr>Rohit Srivastava\u003Cbr>Associate Director, Statistical Programming |  |  Date (dd-Mmm-yyyy) |\n| Hiren Mehta\u003Cbr>Senior Pharmacokineticist, Pharmacokinetics |  |  Date (dd-Mmm-yyyy) |\n\n\n| APPROVALS |\n| --- |\n| Trevi Therapeutics, Inc. |\n|  |\n| Thomas Sciascia, MD  Date (dd-Mmm-yyyy)\u003Cbr>Chief Medical Officer |\n\nTABLE OF CONTENTS  \nCONTENTS  \nREVISION HISTORY .................................................................................................2  \nTABLE OF CONTENTS ............................................................................................. 5  \n1. GLOSSARY OF ABBREVIATIONS.................................................................9  \n2. PURPOSE...................................................................................................... 12  \n2.1. Responsibilities ................................................................................................................. 12  \n2.2. Timings of Analyses .......................................................................................................... 12  \n3. STUDY OBJECTIVES ................................................................................... 13  \n3.1. Exploratory Objectives ...................................................................................................... 13  \n3.2. Brief Description ................................................................................................................ 13  \n3.3. Subject Selection ............................................................................................................... 15  \n3.3.1. Inclusion Criteria ......................................................................................................... 15  \n3.3.2. Exclusion Criteria .......................................","cbCaivnMFXw8kGbl","https://ap.wps.com/l/cbCaivnMFXw8kGbl","pdf",1425797,65,"English","# Revision History\n# Table of Contents\n## 1. Glossary of Abbreviations\n## 2. Purpose\n## 2.1. Responsibilities\n## 2.2. Timings of Analyses\n## 3. Study Objectives\n## 3.1. Exploratory Objectives\n## 3.2. Brief Description\n## 3.3. Subject Selection\n## 3.3.1. Inclusion Criteria\n## 3.3.2. Exclusion Criteria\n## 3.3.3. Naloxone Challenge\n## 3.4. Determination of Sample Size\n## 3.5. Treatment Assignment & Blinding\n## 3.6. Administration of Study Medication\n## 3.7. Study Procedures and Flowchart\n## 4. Endpoints\n## 5. Change from Analysis Planned in Protocol\n## 6. Analysis Populations\n## 7. General Aspects for Statistical Analysis","[{\"question\":\"What is the TR08 study designed to evaluate?\",\"answer\":\"TR08 evaluates the oral abuse potential of nalbuphine solution and extended-release intact tablets relative to hydromorphone solution and placebo in nondependent, recreational opioid users.\"},{\"question\":\"What study design features are specified in the protocol?\",\"answer\":\"The protocol specifies a randomized, double-blind, double-dummy, active- and placebo-controlled, two-part, 7-way crossover design.\"},{\"question\":\"Where are study purpose, responsibilities, and analysis timing described?\",\"answer\":\"These are covered under the Purpose section, including Responsibilities and Timings of Analyses in the Table of Contents.\"}]","TR08 - A Randomized, Double-Blind, Double-Dummy, Active-and Placebo-Controlled, Two-Part, 7-Way Crossover Study - Protocol | PDF",164]