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  • Section 3.1.3 The Findings Observation Class
    • --CELLEV, Number of Cells Evaluated
  • Section 3.1.4, Identifiers for All Classes
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    • SPTOBID, Applicant-defined Tobacco Product Identifier
    • IGDCMPID, Ingredient or Component Identifier
    • STOCONID, Applicant-defined Storage Conditions ID

Many variable labels, notes, definitions, or examples were modified. In most cases, these modifications were to use the phrase "treatment or product" for the case when product use is not considered a treatment.

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In some cases a definition was added where there was none before.
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The  The type and location of revisions made are described in the following tables.

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VARIABLESjira

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Modifications made to existing Variable

Variable

Section

Label

Notes

Definition

Examples

--TRT

Section 3.1.1, The Interventions Observation Class

X

X

X


--RSDISC

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Section 3.1.1, The Interventions Observation Class

X

X



--DOSFRM

Section 3.1.1, The Interventions Observation Class



X


--DOSFRQ

Section 3.1.1, The Interventions Observation Class



X


--DOSTOT

Section 3.1.1, The Interventions Observation Class



X


--DOSRGM

Section 3.1.1, The Interventions Observation Class



X


--ACN

Section 3.1.2, The Events Observation Class

X


X


--ACNOTH

Section 3.1.2, The Events Observation Class



X


--REL

Section 3.1.2, The Events Observation Class



X


--SPEC

Section 3.1.3, The Findings Observation Class



X

X

--XDY

Section 3.1.5, Timing Variables for All Classes



X

--XENDY

Section 3.1.5, Timing Variables for All Classes



X

--XSTDY

Section 3.1.5, Timing Variables for All Classes



X

ACTARMUD

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Section 3.2.1, Demographics


X

RFENDTC

Section 3.2.1, Demographics


X

RFSTDTC

Section 3.2.1, Demographics


X

RFXENDTC

Section 3.2.1, Demographics

X
X

RFXSTDTC

Section 3.2.1, Demographics

X
X

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