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The statistical analysis plan defines analyses to be performed on study data based on the study protocol, finalized prior to enrollment. 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It is finalized prior to enrollment of the first study subject.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"How will performance of Princess®VOLUME Lidocaine be evaluated?",{"text":118,"@type":114},"Performance will be assessed by the investigator using nasolabial folds severity rating scale (NLF-SRS) and the global aesthetic improvement scale (GAIS). Assessments are scheduled for specified follow-up weeks and compared to Day 0.",{"name":120,"@type":111,"acceptedAnswer":121},"What safety and additional analyses are included?",{"text":122,"@type":114},"Safety will be evaluated based on the occurrence of adverse events collected throughout the investigation. The plan also addresses missing values, database closure and data review, and specifies analysis sets and evaluation of additional endpoints.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},203116,1788555788,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":130,"read_time":145,"preview_page_count":14,"preview_urls":146},1374404730887,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","| Statistical Analysis Plan  \u003Cbr>for  \u003Cbr>Final Analysis  \u003Cbr>Version 1.0   |\n| --- |\n\nStudy:A prospective,open label,multicenter,post market study evaluatingPrincess®VOLUME Lidocaine for the correction of nasolabial folds  \nStudy-ID:  \nCPH-401-201258  \nSponsor/Contact:CROMA-PHARMA GmbHIndustriezeile 62100 LeobendorfAustria  \nEvaluation:  \ncode  \n3381  \nVersion:  \n1.0 of 15Dec2016  \nPrevious versions:  \nThe content of this statistical analysis plan is confidential and must not be passed to any thirdparty without permission of CROMA-PHARMA GmbH.  \n\n| Version   | Author   | Date   | Reason for Revision   |\n| --- | --- | --- | --- |\n| 1.0   |  | 15Dec2016   | Final Version 1.0   |\n\nRevision history  \n15Dec2016  \nTable of Contents  \nTABLE OF CONTENT…………………………………………………………………………………………………………………………………………………3  \nLIST OF ABBREVIATION……………………………………………………………………………………………………………………………………………4  \n1 GENERAL………………………………………………………………………………………………………………………………………………………………5  \n2 PERFORMANCE AND SAFETY ENDPOINTS…………………………………………………………………………………………………6  \n2.1 Primary Performance Endpoint. ……………………………………………………………………………………………………………6  \n2.2 econdary Performance Endpoint ………………………………………………………………………………………………………6  \n2.3 Safety Endpoints………………………………………………………………………………………………………………………………………6  \n2.4 Additional Endpoints ………………………………………………………………………………………………………………………………6  \n3 STATISTICAL ANALYSIS SETS …………………………………………………………………………………………………………………………7  \n3.2 Intention-to-treat Population (ITT)…………………………………………………………………………………………………………7  \n3.3 Modified Intent-to-treat Population(modITT)………………………………………………………………………………………7  \n3.4 Per-Protocol Set(PP)………………………………………………………………………………………………………………………………7  \n3.5 Assignment of Analysis Sets to Analysis ………………………………………………………………………………………………7  \n3.6 Visit Terminolog…………………………………………………………………………………………………………………………………………7  \n4 STATISTICAL EVALUATION………………………………………………………………………………………………………………………………8  \n4.1 Dispositions of Subjects and Analysis Set………………………………………………………………………………………………  \n4.2 Demographics and Other Covariates………………………………………………………………………………………………………8  \n4.3 Performance Analysis …………………………………………………………………………………………………………………………9  \n4.3.1 Analysis of Primary Performance Endpoint…………………………………………………………………………………………9  \n4.3.2 Analysis of Secondary Performance Endpoint. ………………………………………………………………………………9  \n4.4 Analysis of Additional Endpoints …………………………………………………………………………………………………………10  \n4.5 Safety Analysis………………………………………………………………………………………………………………………………………10  \n4.6 Missing Values………………………………………………………………………………………………………………………………………10  \n4.7 Data Base Closure and Data Review………………………………………………………………………………………………10  \n4.8 Miscellaneou. ………………………………………………………………………………………………………………………………………11  \n6 DEVIATIONS FROM THE PROTOCOL……………………………………………………………………………………………………………12  \n7 SIGNATURES………………………………………………………………………………………………………………………………………………………13  \n# List of Abbreviations\n\nIn the following abbreviations are listed as used within this statistical analysis plan or which mightoccur within the tables and listings:  \nAEAdverse eventBMIBody mass indexClConfidence intervalCRFCase report formITTIntent-to-treatGAISGlobal aesthetic improvement scaleMedDRAMedical dictionary for regulatory activitiesmodlTTmodified ITTNNumber of subjectsPPPer-protocolPTPreferred termSAESerious adverse eventSAFSafety analysis setSAPStatistical analysis planSDStandard deviationSOCSystem organ classTLGTables,listings,graphsNPRSNumeric pain rating scaleNLF-SRSNasolabial folds severity rating scaleWHO-DDWorld health organization drug dictionary  \n# 1 General\n\nThis statistical analysis plan (SAP)was defined by the sponsor and the responsible statistician.Itis based upon the study protocol (version 3.0 of 31Oct2016)and contains detailed description ofthe statistical methods described therein.  \nThe SAP describes prospectively the analyses to be performed on study data.It was finalized prior toenrolment of first study subject.  \nStudy design and obiectives  \nThis is a prospective,open label,multicenter,post-market inves","cbCaipDIbkK0C7AI","https://ap.wps.com/l/cbCaipDIbkK0C7AI","pdf",1831687,13,"English","# TABLE OF CONTENT\n## LIST OF ABBREVIATION\n## 1 GENERAL\n## 2 PERFORMANCE AND SAFETY ENDPOINTS\n### 2.1 Primary Performance Endpoint\n### 2.2 econdary Performance Endpoint\n### 2.3 Safety Endpoints\n### 2.4 Additional Endpoints\n## 3 STATISTICAL ANALYSIS SETS\n### 3.2 Intention-to-treat Population (ITT)\n### 3.3 Modified Intent-to-treat Population (modITT)\n### 3.4 Per-Protocol Set (PP)\n### 3.5 Assignment of Analysis Sets to Analysis\n### 3.6 Visit Terminolog\n## 4 STATISTICAL EVALUATION\n### 4.1 Dispositions of Subjects and Analysis Set\n### 4.2 Demographics and Other Covariates\n### 4.3 Performance Analysis\n### 4.4 Analysis of Additional Endpoints\n### 4.5 Safety Analysis\n### 4.6 Missing Values\n### 4.7 Data Base Closure and Data Review\n### 4.8 Miscellaneou\n## 6 DEVIATIONS FROM THE PROTOCOL\n## 7 SIGNATURES","[{\"question\":\"What is the purpose of this statistical analysis plan?\",\"answer\":\"It defines the statistical methods and analyses to be performed on the study data based on the study protocol for the final analysis. It is finalized prior to enrollment of the first study subject.\"},{\"question\":\"How will performance of Princess®VOLUME Lidocaine be evaluated?\",\"answer\":\"Performance will be assessed by the investigator using nasolabial folds severity rating scale (NLF-SRS) and the global aesthetic improvement scale (GAIS). Assessments are scheduled for specified follow-up weeks and compared to Day 0.\"},{\"question\":\"What safety and additional analyses are included?\",\"answer\":\"Safety will be evaluated based on the occurrence of adverse events collected throughout the investigation. The plan also addresses missing values, database closure and data review, and specifies analysis sets and evaluation of additional endpoints.\"}]","Statistical Analysis Plan for Final Analysis - Version 1.0 | PDF",33,[147,151],{"page_no":8,"url":148,"width":149,"height":150},"https://res-academy.cache.wpscdn.com/upload/kdocshare/2026-11-08/8684c188914e5a88e0a74edf434640df.webp",983,1389,{"page_no":14,"url":152,"width":153,"height":154},"https://res-academy.cache.wpscdn.com/upload/kdocshare/2026-11-08/78077d581ceeeb8327f32cbcbb6c75a5.webp",982,1388]