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Many variable labels, notes, and definitions, or examples were revised to refer to . In most cases, these revisions were to use the phrase 'treatment or product' for the case when product use is not considered a treatment. The variable label, definition, and/or notes associated with the following variables have been changed as type of revisions made are described in the tables below:

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keySDTM-711

Section 3.1.1 The Interventions Observation Class


Changes Revisions made

Variable

Label

NotesDefinition

--TRT

XXX
--RSDISCXXX
--DOSFRM

X

--DOSFRQ



X

--DOSTOT



X

--DOSRGM



X

Section 3.1.2 The Events Observation Class


Changes Revisions made

Variable

Label

NotesDefinition

--ACN

X
X

--ACNOTH



X

--REL



X


Section 3.1.3 The Findings Observation Class


Revisions made

Variable

Label

NotesDefinitionExamples

--SPEC

X
XX


...