# Table 14-3.01 Primary Endpoint - TLF Specification

## Header
- **Table ID**: 14-3.01
- **Title**: Primary Endpoint Analysis - ADAS-Cog (11) Change from Baseline to Week 24 (LOCF)
- **Population**: Efficacy Population

## Analysis Model
- **Method**: ANCOVA (Analysis of Covariance)
- **Model**: CHG ~ TRTPN + SITEGR1 + BASE
- **Type**: Type III Sum of Squares
- **Weighting**: Proportional weighting
- **Dose Response**: Linear trend test (p-value)
- **Pairwise Comparisons**: Placebo vs each active dose

## Missing Data Handling
- **Method**: LOCF (Last Observation Carried Forward)
- **Implementation**: DTYPE = 'LOCF' flag in ADADAS dataset
- **Records**: 163 LOCF records at Week 24

## Table Structure
| Section | Content |
|---------|---------|
| Baseline | n, Mean (SD) by treatment group |
| Week 24 | n, Mean (SD) by treatment group |
| Change from Baseline | n, Mean (SD) by treatment group |
| Statistical Analysis | Dose response p-value, Pairwise LS Means, 95% CI |

## Data Source
- **Dataset**: ADADAS
- **Parameter**: PARAMCD = 'ACTOT'
- **Analysis flag**: ANL01FL = 'Y'
- **Visit**: AVISITN = 24 (Week 24)
- **Change variable**: CHG
- **Baseline variable**: BASE
- **Treatment variable**: TRTPN
- **Population filter**: EFFFL = 'Y'

## Footnotes
1. Efficacy Population: Subjects with at least one post-baseline efficacy assessment.
2. ANCOVA model: Change from Baseline = Treatment + Pooled Site Group + Baseline Score.
3. LOCF = Last Observation Carried Forward for post-baseline missing values.
