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Comment: Removed Xs for Definition for --RSDISC and ACTARMUD. Fixed list of new variables by adding missing varibles and variable labels. Removed new variables from table. Removed New Variable column from table.

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New variables have been added to the following sections:

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

Some new variables

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have been added to sections,
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as noted in the New Variable column in the Variables table.

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. A significant change was made to the definition of --SPEC.
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The type and location of revisions made are described in the following tables.

VARIABLES

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Modifications made to existing Variable

Variable

Section

New Variable

Label

Notes

Definition

Usage Restrictions?

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 ClassX

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

--CELLEV

Section 3.1.3, The Findings Observation Class



X

GNTXAID

Section 3.1.4, Identifiers for All Classes

Section 5.1.2, Trial Sets

Section 5.1.6, Trial Summary Information

X

SPTOBID

Section 3.1.4, Identifiers for All Classes


XSTOCONID

Section 3.1.4, Identifiers for All Classes

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


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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