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The plan defines trial identifiers, investigators, and roles, and structures the analysis around hypotheses, objectives, endpoints, and study methods. It details sample-size determination, general analytical considerations, and reporting conventions. Diagnostic performance analysis is specified to support evidence-based validation of the imaging approach, including technical details and sample tables for data reporting.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/statistical-analysis-plan-version-10/265943/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/statistical-analysis-plan-version-10/265943.png","ImageObject",300,407,{"name":92,"@type":93},"Finn","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-17","2026-09-14",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What study does this Statistical Analysis Plan cover?","Question",{"text":112,"@type":113},"It covers a cross-sectional study assessing muscle perfusion in patients with PAD using non-invasive Multispectral Optoacoustic Tomography.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which trial identifiers and principal roles are documented?",{"text":117,"@type":113},"The plan lists the ClinicalTrials.gov identifier (NCT04641091), the principle investigator, and authors including the reviewing statistician and local sponsor.",{"name":119,"@type":110,"acceptedAnswer":120},"What are the key components of the analysis described in the Table of Contents?",{"text":121,"@type":113},"It includes hypotheses and endpoints, study methods, sample size determination, general considerations, summary of study data, diagnostic performance analysis, and reporting technical details with sample tables.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},265943,1790026005,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},34359740700684,"https://ap-avatar.wpscdn.com/avatar/1f400023980c374ae676?_k=1777273430885731487","Statistical Analysis Plan  \n\n| Trial Short Title | MSOT_PAD |\n| --- | --- |\n| Trial full Title | Cross-sectional study of muscle perfusion in patients with PAD by non-invasive Multispectral Optoacoustic Tomography. |\n| [ClinicalTrials.gov](ClinicalTrials.gov) Identifier | NCT04641091 |\n| Trial Principle Investigator | [PD Dr. med. Ulrich Rother](PD Dr. med. Ulrich Rother) |\n| Statistical Analysis Plan Authors | PD [Dr. med. Ulrich](Dr. med. Ulrich) Rother, Josefine Günther, Anna Träger |\n| Reviewing Statistician | [Prof. Dr. med. Wolfgang](Prof. Dr. med. Wolfgang) Uter |\n| Local Sponsor | Department of Vascular Surgery\u003Cbr>University Hospital Erlangen |\n| Document Version | Version 1.0 |\n| Document Version Date | 04/12/2021 |\n\nTable of Contents  \n1 Version History ............................................................................................................... 3  \n2 List of Abbreviations and Definition of Terms .................................................................. 3  \n3 Introduction .................................................................................................................... 3  \n4 Hypothesis, Study Objectives and Endpoints ................................................................. 4  \n5 Study Methods ............................................................................................................... 7  \n6 Determination of Sample Size .......................................................................................12  \n7 General Considerations .................................................................................................12  \n8 Summary of Study Data ................................................................................................13  \n9 Diagnostic Performance Analysis ..................................................................................14  \n10 Reporting Convention ................................................................................................15  \n11 Technical Details .......................................................................................................15  \n12 Sample Tables for Data Reporting .............................................................................16  \n1 Version History  \n\n| Version | Changes | Authors |\n| --- | --- | --- |\n| 1.0 |  |  |\n\n2 List of Abbreviations and Definition of Terms  \nAAA ................................ ................................ ..................... Siehe abdominal aortic aneurysm ABI ................................ ................................ ................................ Siehe Ankle-Brachial Index CCDS ................................ .............................. Siehe color-coded vascular duplexsonography CFA ................................ ................................ .......................... Siehe Common femoral artery CHD ................................ ................................ ........................... Siehe coronary heart disease CHF................................ ................................ ................................ Siehe chronic heart failure CIA ................................ ................................ ................................ .. Siehe common iliac artery CKD ................................ ................................ ........................... Siehe chronic kidney disease CLTI ................................ ................................ .......... Siehe chronic limb threatening ischemia DGA .................. Siehe Deutsche Gesellschaft für Angiologie (German Society for Angiology) EIA ................................ ................................ ................................ ... Siehe external iliac artery Hb ................................ ................................ ........................ Siehe deoxygenated hemoglobin HbO2 ................................ ................................ ........................ Siehe oxygenated hem","cbCainsAD9NJHGxQ","https://ap.wps.com/l/cbCainsAD9NJHGxQ","pdf",693795,22,"English","# Version History\n# List of Abbreviations and Definition of Terms\n# Introduction\n## Preface\n# Hypothesis, Study Objectives and Endpoints\n# Study Methods\n# Determination of Sample Size\n# General Considerations\n# Summary of Study Data\n# Diagnostic Performance Analysis\n# Reporting Convention\n# Technical Details\n# Sample Tables for Data Reporting","[{\"question\":\"What study does this Statistical Analysis Plan cover?\",\"answer\":\"It covers a cross-sectional study assessing muscle perfusion in patients with PAD using non-invasive Multispectral Optoacoustic Tomography.\"},{\"question\":\"Which trial identifiers and principal roles are documented?\",\"answer\":\"The plan lists the ClinicalTrials.gov identifier (NCT04641091), the principle investigator, and authors including the reviewing statistician and local sponsor.\"},{\"question\":\"What are the key components of the analysis described in the Table of Contents?\",\"answer\":\"It includes hypotheses and endpoints, study methods, sample size determination, general considerations, summary of study data, diagnostic performance analysis, and reporting technical details with sample tables.\"}]","Statistical Analysis Plan - Version 1.0 | PDF",1789402749,55]