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PHARMASUG 2020
1 . PharmaSUG 2020 - Paper PO-176 . 10 things you need to know about PMDA eSubmission . Yuichi Nakajima, Novartis Pharma K.K. ABSTRACT From April 2020, Pharmaceuticals and Medical Devices Agency (PMDA), healthauthority in Japan,
PHARMASUG 2020
1 . PharmaSUG 2020 - Paper DS - 110 . Demystifying SDTM OE, MI, and PR Domains . Lyma Faroz, Seattle Genetics , Inc., Bothell WA . Sruthi Kola, Seattle Genetics, Inc SAS SYSTEM AND SAS PROGRAM VALIDATION TECHNIQUES 1 SAS System and SAS Program Validation Techniques Sy Truong, Meta-Xceed, Inc., San Jose, CA ABSTRACT This course will teach methodologies of performing TABLES, LISTINGS & FIGURES METADATA AND TRACEABILITY PhUSE US Connect 2020 1 Paper SI12 Tables, Listings & Figures Metadata and Traceability Judith Goud, Nurocor, The Netherlands ABSTRACT Consistent representations of the collected data are important for internal data review as well as regulatory submissions. MACRO MADNESS: CREATING MACRO CALLS WITH PROC FREQ The syntax is as follows: %IF --expression--%THEN --action--; %ELSE --action--; *NOTE: the %ELSE statement is optional; ‘Expression’ can be a comparison or any other regular type of statement that you would put into a data step IF statement. However, using data step variables in a %IF expression is NOT allowed, only macro PLEASE DON'T MERGE WITHOUT BY 1 Please don't Merge without By !! Monal Kohli ABSTRACT Have you ever merged datasets and forgotten a by Statement, looked at the results and thought wow -- 100% MIXED MODEL REPEATED MEASURES (MMRM) References 1. SAS Institute Inc. 2011. SAS/STAT® 9.2 User’s Guide.Cary, NC: SAS Institute Inc. 2. “Common Statistical Methods for Clinical Research with SAS Examples, Second “TABLE 1” IN SCIENTIFIC MANUSCRIPTS; USING PROC REPORT AND 2 two characteristics. Table 1 (below) shows the end result that we will be striving for. This table shall be produced, as an RTF document, completely through programming without cutting and pasting, or other such manual word- ARE YOU COMPUTING CONFIDENCE INTERVAL USING PROC FREQ Paper CC20 . Are you computing Confidence Interval for binomial proportion using PROC FREQ? Be Careful!! Sandeep Sawant, i3 Statprobe,Mumbai, MH
SAS PROCEEDINGS AND MORE SAS Proceedings and more: Fortune Records, Dave Marsh 1001,PHARMASUG 2020
1 . PharmaSUG 2020 - Paper PO-176 . 10 things you need to know about PMDA eSubmission . Yuichi Nakajima, Novartis Pharma K.K. ABSTRACT From April 2020, Pharmaceuticals and Medical Devices Agency (PMDA), healthauthority in Japan,
PHARMASUG 2020
1 . PharmaSUG 2020 - Paper DS - 110 . Demystifying SDTM OE, MI, and PR Domains . Lyma Faroz, Seattle Genetics , Inc., Bothell WA . Sruthi Kola, Seattle Genetics, Inc SAS SYSTEM AND SAS PROGRAM VALIDATION TECHNIQUES 1 SAS System and SAS Program Validation Techniques Sy Truong, Meta-Xceed, Inc., San Jose, CA ABSTRACT This course will teach methodologies of performing TABLES, LISTINGS & FIGURES METADATA AND TRACEABILITY PhUSE US Connect 2020 1 Paper SI12 Tables, Listings & Figures Metadata and Traceability Judith Goud, Nurocor, The Netherlands ABSTRACT Consistent representations of the collected data are important for internal data review as well as regulatory submissions. MACRO MADNESS: CREATING MACRO CALLS WITH PROC FREQ The syntax is as follows: %IF --expression--%THEN --action--; %ELSE --action--; *NOTE: the %ELSE statement is optional; ‘Expression’ can be a comparison or any other regular type of statement that you would put into a data step IF statement. However, using data step variables in a %IF expression is NOT allowed, only macro PLEASE DON'T MERGE WITHOUT BY 1 Please don't Merge without By !! Monal Kohli ABSTRACT Have you ever merged datasets and forgotten a by Statement, looked at the results and thought wow -- 100% MIXED MODEL REPEATED MEASURES (MMRM) References 1. SAS Institute Inc. 2011. SAS/STAT® 9.2 User’s Guide.Cary, NC: SAS Institute Inc. 2. “Common Statistical Methods for Clinical Research with SAS Examples, Second “TABLE 1” IN SCIENTIFIC MANUSCRIPTS; USING PROC REPORT AND 2 two characteristics. Table 1 (below) shows the end result that we will be striving for. This table shall be produced, as an RTF document, completely through programming without cutting and pasting, or other such manual word- ARE YOU COMPUTING CONFIDENCE INTERVAL USING PROC FREQ Paper CC20 . Are you computing Confidence Interval for binomial proportion using PROC FREQ? Be Careful!! Sandeep Sawant, i3 Statprobe,Mumbai, MH
MIXED MODEL REPEATED MEASURES (MMRM) Paper AS06 Mixed Model Repeated Measures (MMRM) Mrudula Suryawanshi, Syneos Health, Pune, India ABSTRACT This specialized Mixed Models procedure analyzes results from repeated measures designs in which theoutcome (response)
DO LOOPS :INTO EFFICIENT PROGRAMMING: DATA STEP DO LOOP 1 SESUG Paper 253-2019 DO loops :INTO efficient programming: DATA STEP do loop + PROC SQL in boilerplate programming Christopher Hargett, U.S. Department of Commerce RISK-BASED AND EXPOSURE-BASED ADJUSTED SAFETY INCIDENCE RATES 1 PharmaSUG 2020 - Paper SA-103 Risk-based and Exposure-based Adjusted Safety Incidence Rates Qiuhong Jia, Fang-Ting Kuo, Chia-Ling Ally Wu, and Ping Xu, Seattle Genetics, Inc. MACRO MADNESS: CREATING MACRO CALLS WITH PROC FREQ The syntax is as follows: %IF --expression--%THEN --action--; %ELSE --action--; *NOTE: the %ELSE statement is optional; ‘Expression’ can be a comparison or any other regular type of statement that you would put into a data step IF statement. However, using data step variables in a %IF expression is NOT allowed, only macro GROWING GROWTH CURVES USING PROC MIXED AND PROC NLMIXED Paper PR03 Growing Growth Curves Using PROC MIXED and PROC NLMIXED Jeff Gossett, University of Arkansas Medical Sciences, Little Rock, AR Pippa Simpson, University of R FOR SAS PROGRAMMERS: IT'S DIFFERENT, BUT FRIENDLY PhUSE 2014 1 Paper AD04 R for SAS programmers: It’s different, but friendly Friedrich Schuster, HMS Analytical Software GmbH, Heidelberg, Germany ABSTRACT In recent years, a large number of pharmaceutical companies have adopted R as a data analysis tool. TT05 - AN INTRODUCTION TO PYTHON: THE SAS PROGRAMMERS GUIDE PhUSE EU Connect 2019 1 Paper TT05 An Introduction to Python: The SAS Programmers Guide Bradley Harris, GlaxoSmithKline, Uxbridge, UKABSTRACT
OBTAINING A LIST OF FILES IN A DIRECTORY USING SAS® FUNCTIONS Obtaining A List of Files In A Directory Using SAS Functions, continued 3 READING DIRECTORIES RECURSIVELY Reading directories and their subdirectories can be tricky. IS03: AN INTRODUCTION TO SDTM Subject Identifiers (USUBJID & SUBJID) • ‘Subject’ should be used where applicable – consistent with the recommendation in FDA guidance – generically refers to both patients and healthyvolunteers.
SUBMISSION OF SOFTWARE PROGRAMS TO REGULATORY AGENCIES 4 . There are two additional documents on the PMDA website that also describe the requirement to submit software programs to the PMDA. • Basic Principles on Electronic Submission of Study Data for New DrugApplications (2014)
SAS PROCEEDINGS AND MORE 536 papers presented at PHUSE US Connect 2018-2020. PHUSE US Connect 2021. June 14-18 - Virtual Event. 12730 papers presented at SUGI / SAS Global Forum 1976-2021. SAS Global Forum 2021. May 18-20 - Virtual Event. 3649 papers presented at PharmaSUG 1997-2021. PharmaSUG 2021.May 24-28 -
TABLES, LISTINGS & FIGURES METADATA AND TRACEABILITY PhUSE US Connect 2020 1 Paper SI12 Tables, Listings & Figures Metadata and Traceability Judith Goud, Nurocor, The Netherlands ABSTRACT Consistent representations of the collected data are important for internal data review as well as regulatory submissions. MIXED MODEL REPEATED MEASURES (MMRM) Paper AS06 Mixed Model Repeated Measures (MMRM) Mrudula Suryawanshi, Syneos Health, Pune, India ABSTRACT This specialized Mixed Models procedure analyzes results from repeated measures designs in which theoutcome (response)
ADDING ONE VALUE TO ALL OBSERVATIONS 1 Adding One Value to All Observations Anne W. Warren, MDRC, New York, NY ABSTRACT This paper reviews four techniques for adding one value, such as a summary statistic, to all observations in a MIXED MODEL REPEATED MEASURES (MMRM) References 1. SAS Institute Inc. 2011. SAS/STAT® 9.2 User’s Guide.Cary, NC: SAS Institute Inc. 2. “Common Statistical Methods for Clinical Research with SAS Examples, Second R FOR SAS PROGRAMMERS: IT'S DIFFERENT, BUT FRIENDLY PhUSE 2014 1 Paper AD04 R for SAS programmers: It’s different, but friendly Friedrich Schuster, HMS Analytical Software GmbH, Heidelberg, Germany ABSTRACT In recent years, a large number of pharmaceutical companies have adopted R as a data analysis tool. MACRO MADNESS: CREATING MACRO CALLS WITH PROC FREQ The syntax is as follows: %IF --expression--%THEN --action--; %ELSE --action--; *NOTE: the %ELSE statement is optional; ‘Expression’ can be a comparison or any other regular type of statement that you would put into a data step IF statement. However, using data step variables in a %IF expression is NOT allowed, only macro IMPROVING A GRAPH USING PROC GPLOT AND THE GOPTIONS STATEMENT 1 Improving a Graph Using PROC GPLOT and the GOptions Statement Wendi L. Wright, CTB/McGraw-Hill ABSTRACT Starting with a simple SAS PLOTprogram, we will
FORMATTING TIPS AND TECHNIQUES FOR PRINTABLE EXCEL TABLES Formatting Tips and Techniques for Printable Excel Tables Created with the SAS® Excel XP ODS Tagset and PROC REPORT . Kathy Hardis Fraeman, United BioSource Corporation, Bethesda, MD APPLYING INVALUE STATEMENT IN PROC FORMAT FOR ORDERING Page 4 of 8 With formats, one can Display the numeric values in character format (for example, 1 as Male and 2 as Female) Display the character value in character format SAS PROCEEDINGS AND MORE 536 papers presented at PHUSE US Connect 2018-2020. PHUSE US Connect 2021. June 14-18 - Virtual Event. 12730 papers presented at SUGI / SAS Global Forum 1976-2021. SAS Global Forum 2021. May 18-20 - Virtual Event. 3649 papers presented at PharmaSUG 1997-2021. PharmaSUG 2021.May 24-28 -
TABLES, LISTINGS & FIGURES METADATA AND TRACEABILITY PhUSE US Connect 2020 1 Paper SI12 Tables, Listings & Figures Metadata and Traceability Judith Goud, Nurocor, The Netherlands ABSTRACT Consistent representations of the collected data are important for internal data review as well as regulatory submissions. MIXED MODEL REPEATED MEASURES (MMRM) Paper AS06 Mixed Model Repeated Measures (MMRM) Mrudula Suryawanshi, Syneos Health, Pune, India ABSTRACT This specialized Mixed Models procedure analyzes results from repeated measures designs in which theoutcome (response)
ADDING ONE VALUE TO ALL OBSERVATIONS 1 Adding One Value to All Observations Anne W. Warren, MDRC, New York, NY ABSTRACT This paper reviews four techniques for adding one value, such as a summary statistic, to all observations in a MIXED MODEL REPEATED MEASURES (MMRM) References 1. SAS Institute Inc. 2011. SAS/STAT® 9.2 User’s Guide.Cary, NC: SAS Institute Inc. 2. “Common Statistical Methods for Clinical Research with SAS Examples, Second R FOR SAS PROGRAMMERS: IT'S DIFFERENT, BUT FRIENDLY PhUSE 2014 1 Paper AD04 R for SAS programmers: It’s different, but friendly Friedrich Schuster, HMS Analytical Software GmbH, Heidelberg, Germany ABSTRACT In recent years, a large number of pharmaceutical companies have adopted R as a data analysis tool. MACRO MADNESS: CREATING MACRO CALLS WITH PROC FREQ The syntax is as follows: %IF --expression--%THEN --action--; %ELSE --action--; *NOTE: the %ELSE statement is optional; ‘Expression’ can be a comparison or any other regular type of statement that you would put into a data step IF statement. However, using data step variables in a %IF expression is NOT allowed, only macro IMPROVING A GRAPH USING PROC GPLOT AND THE GOPTIONS STATEMENT 1 Improving a Graph Using PROC GPLOT and the GOptions Statement Wendi L. Wright, CTB/McGraw-Hill ABSTRACT Starting with a simple SAS PLOTprogram, we will
FORMATTING TIPS AND TECHNIQUES FOR PRINTABLE EXCEL TABLES Formatting Tips and Techniques for Printable Excel Tables Created with the SAS® Excel XP ODS Tagset and PROC REPORT . Kathy Hardis Fraeman, United BioSource Corporation, Bethesda, MD APPLYING INVALUE STATEMENT IN PROC FORMAT FOR ORDERING Page 4 of 8 With formats, one can Display the numeric values in character format (for example, 1 as Male and 2 as Female) Display the character value in character format MEASURING TEST-RETEST RELIABILITY: THE INTRACLASS KAPPA 2 The chance agreement for Cohen’s kappa also termed the Percentage Agreement Corrected for Chance (PACC) is PQ + P’Q’ where P is the proportion positive for time 1 and Q is the proportion positive fortime
PROC MIXED - RIGHT OPTIONS TO GET THE RIGHT OUTPUT 1 . Proc Mixed - Right Options to get Right Output . Shilpa Edupganti, Eliassen Group, CT . Sheetal Nisal, Independent Consultant, CT . ABSTRACT . The Mixed Procedure fits a variety of mixed linear models to data that enables us to use these fitted models HANDLING DUPLICATE RECORDS IN SDTM FOR EFFECTIVE PHUSE Connect US 2020 . 4 . 2. True double entry per key variables and improper use of additional natural keys In this category, the data has two or more records with most of CALCULATION OF COCHRAN–MANTEL–HAENSZEL STATISTICS FOR The Cochran-Mantel-Haenszel (CMH) test (or Mantel-Haenszel) is an inferential test for the association between two binary variables, while controlling for a third confounding nominal variable (Cochran1954;
OBTAINING A LIST OF FILES IN A DIRECTORY USING SAS® FUNCTIONS Obtaining A List of Files In A Directory Using SAS Functions, continued 3 READING DIRECTORIES RECURSIVELY Reading directories and their subdirectories can be tricky. FORMATTING TIPS AND TECHNIQUES FOR PRINTABLE EXCEL TABLES Formatting Tips and Techniques for Printable Excel Tables Created with the SAS® Excel XP ODS Tagset and PROC REPORT . Kathy Hardis Fraeman, United BioSource Corporation, Bethesda, MD BUILDING A BETTER BAR CHART WITH SAS/GRAPH® SOFTWARE the GPLOT procedure. Unlike GPLOT there are no x-coordinates in GCHART to accommodate continuous data. Instead, the only addressable coordinates in PROC GCHART lie PRACTICAL BENEFITS OF EC: BUILDING A COMPREHENSIVE PhUSE US Connect 2018 2 In the blinded dataset, the exposure term (ECTRT) is a general placeholder. All Data Management activities are performed on the blinded dataset.BIMO LISTINGS
PhUSE US Connect 2018 1 Paper RG07 BIMO Listings – Check That Off Your NDA To-Do List Charanjit Singh Kahlon, Vita Data Sciences, Waltham, MA, USA Dharmendra Tirumalasetti, Vita Data Sciences,Waltham, MA, USA
ORDERING PROC FREQ AROUND 2 ORDER=INTERNAL First, you should know that even without specifying it, PROC FREQ uses option ORDER=INTERNAL by default. This means that the results are printed in the sorting order of the raw values—the internal representation of the variables. SAS PROCEEDINGS AND MORE 536 papers presented at PHUSE US Connect 2018-2020. PHUSE US Connect 2021. June 14-18 - Virtual Event. 12730 papers presented at SUGI / SAS Global Forum 1976-2021. SAS Global Forum 2021. May 18-20 - Virtual Event. 3649 papers presented at PharmaSUG 1997-2021. PharmaSUG 2021.May 24-28 -
DO LOOPS :INTO EFFICIENT PROGRAMMING: DATA STEP DO LOOP 1 SESUG Paper 253-2019 DO loops :INTO efficient programming: DATA STEP do loop + PROC SQL in boilerplate programming Christopher Hargett, U.S. Department of Commerce ADDING ONE VALUE TO ALL OBSERVATIONS 1 Adding One Value to All Observations Anne W. Warren, MDRC, New York, NY ABSTRACT This paper reviews four techniques for adding one value, such as a summary statistic, to all observations in a USING AND UNDERSTANDING LSMEANS AND LSMESTIMATE 1 Using and Understanding LSMEANS and LSMESTIMATE David J. Pasta, ICON, San Francisco, CA . ABSTRACT . The concept of least squares means, or population marginal means, seems to THE SPARSE OPTION IN PROC FREQ: LITTLE KNOWN, YET POWERFUL 1 The Sparse Option in PROC FREQ: Little Known, Yet Powerful By Chris Moriak, AstraZeneca, Wilmington, DE Abstract Have you ever needed to know all the possible LOGISTIC AND LINEAR REGRESSION ASSUMPTIONS: VIOLATION 2 . screenings were conducted on a group of patients. Three months after the initial screening, follow-up data was collected from a second screening that included additional information such MIXED MODEL REPEATED MEASURES (MMRM)MIXED MODEL REPEATED MEASURES MMRMMIXED MODEL REPEATED MEASURES MMRM References 1. SAS Institute Inc. 2011. SAS/STAT® 9.2 User’s Guide.Cary, NC: SAS Institute Inc. 2. “Common Statistical Methods for Clinical Research with SAS Examples, Second PROC SQL VERSUS THE DATA STEP Proc SQL versus The Data Step JoAnn Matthews, Highmark Blue Shield, Pittsburgh, PA ABSTRACT Most data within organizations is stored in relational databases. DEVELOPING AN ANALYTICS CENTER OF EXCELLENCE (OR THE CAREANALYTICS CENTER OF EXCELLENCEANALYTICS CENTER OF EXCELLENCEANALYTICS CENTER OFEXCELLENCE ACE
Developing an Analytics Center of Excellence, continued 2 process.” As we’ll see, analytical excellence will come from building a team that makes a habit of strong analytical, IMPROVING A GRAPH USING PROC GPLOT AND THE GOPTIONS STATEMENT 1 Improving a Graph Using PROC GPLOT and the GOptions Statement Wendi L. Wright, CTB/McGraw-Hill ABSTRACT Starting with a simple SAS PLOTprogram, we will
SAS PROCEEDINGS AND MORE SAS Proceedings and more: Fortune Records, Dave Marsh 1001, DO LOOPS :INTO EFFICIENT PROGRAMMING: DATA STEP DO LOOP 1 SESUG Paper 253-2019 DO loops :INTO efficient programming: DATA STEP do loop + PROC SQL in boilerplate programming Christopher Hargett, U.S. Department of Commerce ADDING ONE VALUE TO ALL OBSERVATIONS 1 Adding One Value to All Observations Anne W. Warren, MDRC, New York, NY ABSTRACT This paper reviews four techniques for adding one value, such as a summary statistic, to all observations in a USING AND UNDERSTANDING LSMEANS AND LSMESTIMATE 1 Using and Understanding LSMEANS and LSMESTIMATE David J. Pasta, ICON, San Francisco, CA . ABSTRACT . The concept of least squares means, or population marginal means, seems to THE SPARSE OPTION IN PROC FREQ: LITTLE KNOWN, YET POWERFUL 1 The Sparse Option in PROC FREQ: Little Known, Yet Powerful By Chris Moriak, AstraZeneca, Wilmington, DE Abstract Have you ever needed to know all the possible LOGISTIC AND LINEAR REGRESSION ASSUMPTIONS: VIOLATION 2 . screenings were conducted on a group of patients. Three months after the initial screening, follow-up data was collected from a second screening that included additional information such MIXED MODEL REPEATED MEASURES (MMRM)MIXED MODEL REPEATED MEASURES MMRMMIXED MODEL REPEATED MEASURES MMRM References 1. SAS Institute Inc. 2011. SAS/STAT® 9.2 User’s Guide.Cary, NC: SAS Institute Inc. 2. “Common Statistical Methods for Clinical Research with SAS Examples, Second PROC SQL VERSUS THE DATA STEP Proc SQL versus The Data Step JoAnn Matthews, Highmark Blue Shield, Pittsburgh, PA ABSTRACT Most data within organizations is stored in relational databases. IMPROVING A GRAPH USING PROC GPLOT AND THE GOPTIONS STATEMENT 1 Improving a Graph Using PROC GPLOT and the GOptions Statement Wendi L. Wright, CTB/McGraw-Hill ABSTRACT Starting with a simple SAS PLOTprogram, we will
DEVELOPING AN ANALYTICS CENTER OF EXCELLENCE (OR THE CAREANALYTICS CENTER OF EXCELLENCEANALYTICS CENTER OF EXCELLENCEANALYTICS CENTER OFEXCELLENCE ACE
Developing an Analytics Center of Excellence, continued 2 process.” As we’ll see, analytical excellence will come from building a team that makes a habit of strong analytical, MIXED MODEL REPEATED MEASURES (MMRM) Paper AS06 Mixed Model Repeated Measures (MMRM) Mrudula Suryawanshi, Syneos Health, Pune, India ABSTRACT This specialized Mixed Models procedure analyzes results from repeated measures designs in which theoutcome (response)
COMPARING VALUES ACROSS OBSERVATIONS: BE CAREFUL Comparing Values Across Observations: Be Careful . Prafulla Girase, IMS Health, Watertown, MA . ABSTRACT . There are several techniquesthat can be used
AVOIDING SINKHOLES: COMMON MISTAKES DURING ADAM DATA SET Avoiding Sinkholes: Common Mistakes During ADaM Data set Implementation, continued 3 Illustration Table 1 and . Table 2 illustrate the concept of variable harmonization. STATISTICS AND PHARMACOKINETICS IN CLINICAL PHARMACOLOGY WHAT IS PHARMACOKINETICS • The study of what the body does to the drug • We are interested in ADME, the Absorption (The disappearance of the compound from the site of administration), Distribution (The transportation of the compound to the rest of the body), Metabolism (The conversion of one molecule (parent) to another of other molecules APPLYING INVALUE STATEMENT IN PROC FORMAT FOR ORDERING Page 4 of 8 With formats, one can Display the numeric values in character format (for example, 1 as Male and 2 as Female) Display the character value in character format CONFIDENCE INTERVALS FOR BINOMIAL PROPORTION USING SAS 1 Paper SD103 Confidence Intervals for Binomial Proportion Using SAS®: The All You Need to Know and No More Jiangtang Hu d-Wise,Morrisville, NC
CREATING EXTERNAL FILES USING SAS SOFTWARE 3 are separated by a space. It is the easiest style to code but offers the least control over where and how the data is actually placed inthe file.
LINEAR MIXED MODELS IN CLINICAL TRIALS USING PROC MIXED 1 PharmaSUG2010- Paper SP07 Linear Mixed Models in Clinical Trials using PROC MIXED Danyang Bing, ICON Clinical Research, Redwood City, CA Xiaomin He, ICON Clinical Research, North Wales, PA ORDERING PROC FREQ AROUND 2 ORDER=INTERNAL First, you should know that even without specifying it, PROC FREQ uses option ORDER=INTERNAL by default. This means that the results are printed in the sorting order of the raw values—the internal representation of the variables. INTRODUCTION TO PROC TABULATE 1 Introduction to PROC TABULATE Wendi L. Wright, Educational Testing Service, Princeton, NJ ABSTRACT This introduction to PROC TABULATE first looks at the basic syntax of PROC TABULATEMore ...
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