Statistical Analysis Plan for Final Analysis - Version 1.0

Sep 4, 2026

Uploaded by Pentious

Prospective open-label multicenter post-market investigation evaluating the performance and safety of Princess®VOLUME Lidocaine for correction of nasolabial folds. The statistical analysis plan defines analyses to be performed on study data based on the study protocol, finalized prior to enrollment. It specifies evaluation of primary and secondary performance endpoints using NLF-SRS and GAIS, pain intensity and satisfaction assessments over multiple follow-up weeks, plus safety analyses with adverse event collection and handling of missing data.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages13

Reading Time33 min

AccessFree to download

TABLE OF CONTENT

LIST OF ABBREVIATION

1 GENERAL

2 PERFORMANCE AND SAFETY ENDPOINTS

2.1 Primary Performance Endpoint

2.2 econdary Performance Endpoint

2.3 Safety Endpoints

2.4 Additional Endpoints

3 STATISTICAL ANALYSIS SETS

3.2 Intention-to-treat Population (ITT)

3.3 Modified Intent-to-treat Population (modITT)

3.4 Per-Protocol Set (PP)

3.5 Assignment of Analysis Sets to Analysis

3.6 Visit Terminolog

4 STATISTICAL EVALUATION

4.1 Dispositions of Subjects and Analysis Set

4.2 Demographics and Other Covariates

4.3 Performance Analysis

4.4 Analysis of Additional Endpoints

4.5 Safety Analysis

4.6 Missing Values

4.7 Data Base Closure and Data Review

4.8 Miscellaneou

6 DEVIATIONS FROM THE PROTOCOL

7 SIGNATURES

| Statistical Analysis Plan
for
Final Analysis
Version 1.0 | | --- | Study:A prospective,open label,multicenter,post market study evaluatingPrincess®VOLUME Lidocaine for the correction of nasolabial folds Study-ID: CPH-401-201258 Sponsor/Contact:CROMA-PHARMA GmbHIndustriezeile 62100 LeobendorfAustria Evaluation: code 3381 Version: 1.0 of 15Dec2016 Previous versions: The content of this statistical analysis plan is confidential and must not be passed to any thirdparty without permission of CROMA-PHARMA GmbH. | Version | Author | Date | Reason for Revision | | --- | --- | --- | --- | | 1.0 | | 15Dec2016 | Final Version 1.0 | Revision history 15Dec2016 Table of Contents TABLE OF CONTENT…………………………………………………………………………………………………………………………………………………3 LIST OF ABBREVIATION……………………………………………………………………………………………………………………………………………4 1 GENERAL………………………………………………………………………………………………………………………………………………………………5 2 PERFORMANCE AND SAFETY ENDPOINTS…………………………………………………………………………………………………6 2.1 Primary Performance Endpoint. ……………………………………………………………………………………………………………6 2.2 econdary Performance Endpoint ………………………………………………………………………………………………………6 2.3 Safety Endpoints………………………………………………………………………………………………………………………………………6 2.4 Additional Endpoints ………………………………………………………………………………………………………………………………6 3 STATISTICAL ANALYSIS SETS …………………………………………………………………………………………………………………………7 3.2 Intention-to-treat Population (ITT)…………………………………………………………………………………………………………7 3.3 Modified Intent-to-treat Population(modITT)………………………………………………………………………………………7 3.4 Per-Protocol Set(PP)………………………………………………………………………………………………………………………………7 3.5 Assignment of Analysis Sets to Analysis ………………………………………………………………………………………………7 3.6 Visit Terminolog…………………………………………………………………………………………………………………………………………7 4 STATISTICAL EVALUATION………………………………………………………………………………………………………………………………8 4.1 Dispositions of Subjects and Analysis Set……………………………………………………………………………………………… 4.2 Demographics and Other Covariates………………………………………………………………………………………………………8 4.3 Performance Analysis …………………………………………………………………………………………………………………………9 4.3.1 Analysis of Primary Performance Endpoint…………………………………………………………………………………………9 4.3.2 Analysis of Secondary Performance Endpoint. ………………………………………………………………………………9 4.4 Analysis of Additional Endpoints …………………………………………………………………………………………………………10 4.5 Safety Analysis………………………………………………………………………………………………………………………………………10 4.6 Missing Values………………………………………………………………………………………………………………………………………10 4.7 Data Base Closure and Data Review………………………………………………………………………………………………10 4.8 Miscellaneou. ………………………………………………………………………………………………………………………………………11 6 DEVIATIONS FROM THE PROTOCOL……………………………………………………………………………………………………………12 7 SIGNATURES………………………………………………………………………………………………………………………………………………………13 # List of Abbreviations In the following abbreviations are listed as used within this statistical analysis plan or which mightoccur within the tables and listings: AEAdverse 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 # 1 General This 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. The SAP describes prospectively the analyses to be performed on study data.It was finalized prior toenrolment of first study subject. Study design and obiectives This is a prospective,open label,multicenter,post-market inves

FAQs

What is the purpose of this statistical analysis plan?

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.

How will performance of Princess®VOLUME Lidocaine be evaluated?

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.

What safety and additional analyses are included?

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.

Sep 4, 2026

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