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Supplement 1 This Supplement Contains the Following Items: 1 Supplement 1 This supplement contains the following items: 1. Original protocol 2. Final protocol 3. Updates on original protocol 4. Final statistical analysis plan ORIGINAL PROTOCOL Electro-acupuncture Versus Prucalopride for Severe Chronic Constipation: A Non- inferiority, Multicenter, Randomized Controlled Trial Clinical Sites: 1. Guang’anmen Hospital, China Academy of Chinese Medical Sciences; 2. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine; 3. West China Hospital of Sichuan University; 4. The Third Affiliated Hospital of Zhejiang Chinese Medical University; 5. Hengyang Hospital Affiliated to Hunan University of Chinese Medicine; 6. Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University; 7. The Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 8. The First Hospital of Hunan University of Chinese Medicine; 9. Hubei Provincial Hospital of Traditional Chinese Medicine; 10. Jiangsu Province Hospital of Traditional Chinese Medicine; 11. Shaanxi Province Hospital of Traditional Chinese Medicine; 12. Qingdao Hiser Medical Group; 13. Guangdong Province Hospital of Traditional Chinese Medicine; 14. Wuhan Hospital of Traditional Chinese and Western Medicine. Data Coordinating and Statistical Centers: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Confidentiality Statement This document is the intellectual property of the Investigators. The information provided in this document is strictly confidential and is available for review to the sponsor, investigators, potential investigators, appropriate Ethics Committees, Investigational Review Boards, and other government regulatory bodies. No disclosure should take place without written authorization from the protocol developing investigators, except to the extent necessarily needed to obtain informed consent from potential subjects. 1 Table of Contents 1. Study Contact and Organization ..................................................................................................................... 3 1.1 Study Contacts ............................................................................................................................................ 3 1.2 Recruiting Sites ........................................................................................................................................... 3 1.3 Collaborating Sites ...................................................................................................................................... 5 2. Study Design ...................................................................................................................................................... 5 2.1 Study Overview ........................................................................................................................................... 5 2.2 Background ................................................................................................................................................. 5 2.3 Study Objective and Hypothesis ................................................................................................................ 6 2.4 Methodology ................................................................................................................................................ 6 2.4.1 Trial Design .......................................................................................................................................... 6 2.4.2 Sample Size Calculation ...................................................................................................................... 6 2.4.3 Randomization ..................................................................................................................................... 6 2.4.4 Blinding ................................................................................................................................................ 6 2.4.5 Participants .......................................................................................................................................... 6 2.4.6 Interventions ........................................................................................................................................ 7 2.4.7 Subject Evaluations and Outcomes .................................................................................................... 9 2.4.8 Safety Assessment .............................................................................................................................. 10 2.4.9 Compliance Assessment .................................................................................................................... 12 2.5 Reference ................................................................................................................................................... 12 3. Flowchart ......................................................................................................................................................... 13 Figure 2 Flowchart ......................................................................................................................................... 13 4. Informed Consent ........................................................................................................................................... 14 Informed Consent: Study Introduction ........................................................................................................ 14 Informed Consent: Signature Page ............................................................................................................... 16 5. Quality Control and Quality Guarantee ....................................................................................................... 17 5.1 Quality Control ......................................................................................................................................... 17 5.1.1 Selection of the Trial Design ............................................................................................................. 17 5.1.2 Restriction of the study subject ........................................................................................................ 17 5.1.3 Blinding .............................................................................................................................................. 17 5.1.4 Quality Control Level ........................................................................................................................ 17 5.2 Quality Guarantee .................................................................................................................................... 17 5.3 Compliance Improvement ........................................................................................................................ 17 6. Data Management ........................................................................................................................................... 17 6.1 Flowchart of the Data Management ........................................................................................................ 17 Figure 3 Flowchart of the data management ........................................................................................... 18 6.2 The Raw Data Management and Archiving ........................................................................................... 18 6.3 Data Entry and Storage ............................................................................................................................ 18 6.3.1 Database Building and Testing, Data Entry Interface ................................................................... 18 6.3.2 Data Entry and Inspection ................................................................................................................ 19 6.4 Data Verification and Problems Solving ................................................................................................. 19 6.5 Medical Coding ......................................................................................................................................... 19 6.6 Data Report ............................................................................................................................................... 19 6.7 Data Blinding Review ............................................................................................................................... 19 6.8 Database Locking ...................................................................................................................................... 19 7. Statistical Analysis .......................................................................................................................................... 19 7.1 Objective and Hypothesis ......................................................................................................................... 19 7.2 Statistical Analysis Set .............................................................................................................................. 20 7.3 Statistical Methods .................................................................................................................................... 20 8. Ethical Principles ............................................................................................................................................ 20 2 1. Study Contact and Organization
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