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added page breaks for each new Header1 section. Still need to figure …
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…out how to start TOC on new page.
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laxamanaj committed Feb 29, 2024
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Expand Up @@ -79,12 +79,12 @@ This was a prospective, randomized, multi-center, double-blind, placebo-controll

300 subjects total (100 subjects in each of 3 groups)

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### Study schema:

![](adrg_images/Screenshot%202024-02-28%20223852.png){fig-align="center"}

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# Analysis Considerations Related to Multiple Analysis Datasets

## Core Variables
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For ASTDT in ADAE, this date was converted to numeric SAS date from AE.AESTDTC. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed. See define.xml.

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# Analysis Data Creation and Processing Issues

## Split Datasets
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No intermediate datasets were created for this trial.

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# Analysis Dataset Descriptions

## Overview
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ADTTE contains one observation per parameter per subject. ADTTE is specifically for safety analyses of the time to the first dermatologic adverse event. Dermatologic AEs are considered an adverse event of special interest. The key parameter used for the analysis of time to the first dermatological event is with PARAMCD of "TTDE".

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# Data Conformance Summary

## Conformance Inputs
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[Common Issues](https://github.com/RConsortium/submissions-pilot3-adam/wiki/Common-Issues)

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# Submission of Programs

## Description
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| xportr | 0.2.0 | Tools to build CDISC compliant data sets and check for CDISC compliance. |
+------------------------------------+---------------------+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+

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# Directory Structure

m5
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        \|   │   │   ├── define2-0-0.xsl

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# Appendix

## Appendix 1: Pilot 3 Installation and Usage
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