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The following example illustrates calculation of some of the statistics typically calculated on product stability measures.

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Dataset wrap
Name

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adpt

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Dataset2
tableidadpt
RowSTUDYID

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PRODSTID

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SPTOBIDSTOCONID
PARQUALPARAM

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PARAMCD

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AVAL

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ATPT

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ATPTN

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1

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ADPT

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TOB07Smokeless01/Condition 1Smokeless01Condition

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1Product Moisture (%)AverageAVERAGE

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51.95667Week 01
2TOB07Smokeless01/Condition 1Smokeless01Condition

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1Product Moisture (%)S.D.STD

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0.025166Week 01
3

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TOB07Smokeless01

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/Condition 1Smokeless01Condition

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1Product Moisture (%)% RSDPCTRSD

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0.048437Week 01
4

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TOB07Smokeless01

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/Condition 1

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Smokeless01Condition 1

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Product Moisture (%)

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Average

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AVERAGE

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51.

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72333

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Week 8

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2
5

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TOB07Smokeless01

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/Condition 1

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Smokeless01Condition 1

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Product Moisture (%)S.D.STD

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0.046188Week 82
6

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TOB07Smokeless01

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/Condition 1

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Smokeless01Condition 1

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Product Moisture (%)

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% RSD

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PCTRSD

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0.

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089298Week 82
7TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)AverageAVERAGE52.31333Week 243
8TOB07Smokeless01/Condition 1Smokeless01Condition 1Product Moisture (%)S.D.STD

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0.327465Week 243
9

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TOB07Smokeless01

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/Condition 1Smokeless01Condition

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1

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Product Moisture (%)% RSDPCTRSD

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0.625969Week 243
10TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)AverageAVERAGE51.95667Week 01
11TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)

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S.D.STD

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0.025166Week 01
12TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)

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% RSDPCTRSD

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0.048437Week 01
13

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TOB07Smokeless01

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/Condition 2Smokeless01Condition 2Product Moisture (%)

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AverageAVERAGE

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51.80333Week 82
14TOB07Smokeless01

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/Condition 2Smokeless01Condition 2Product Moisture (%)

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S.D.STD

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0.035119Week 82
15

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TOB07Smokeless01

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/Condition 2Smokeless01Condition 2Product Moisture (%)

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% RSDPCTRSD

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0.067793Week 82
16TOB07Smokeless01

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/Condition 2Smokeless01Condition 2Product Moisture (%)

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AverageAVERAGE

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52.08667Week 243
17TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)

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S.D.STD

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shelf life factor

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statistic

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text?

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1

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shelf life factor

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statistic

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1

0.188237Week 243
18TOB07Smokeless01/Condition 2Smokeless01Condition 2Product Moisture (%)% RSDPCTRSD0.361393Week 243
Definexmltable
LevelDataset
PurposeAnalysis
OIDADPT
NameADPT
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADPTProduct Stability Analysis DatasetADAM OTHERone record per product stability identifier per parameter qualifier per parameter per analysis timepointAnalysisPRODSTID, PARQUAL, PARAM, ATPTadpt.xptNA
Definexmltable
DatasetADPT
LevelVariable
PurposeAnalysis
NameADPT
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqPT.STUDYID
PRODSTIDProduct Stability IdentifierChar
ReqConcatenate SPTOBID with STOCONID separated with '/'
SPTOBIDApplicant-Defined Tobacco Product IDChar
PermPT.SPTOBID
STOCONIDApplicant-Defined Storage Conditions IDChar
PermPT.STOCONID
PARQUALParameter QualifierChar
CondSet to the item being tested
PARAMParameterChar
ReqSet to the parameter being captured
PARAMCDParameter CodeChar
ReqSet to the parameter code associated with the parameter
AVALAnalysis ValueNum
ReqCalculated statistic
ATPTAnalysis TimepointChar
CondPT.PTTPT
ATPTNAnalysis Timepoint (N)Num
CondPT.PTTPTNUM

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shelf life factor

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statistic

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1

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shelf life factor

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statistic

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Condition 2 (A °C/ B %RH)

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10

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shelf life factor

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statistic

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10

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shelf life factor

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statistic

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