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Add detailed guidelines for Clinical Decision Support documents. Updated document types, capabilities, and best practices for generating evidence-based treatment recommendations and patient cohort analyses. Improved clarity and organization throughout the documentation.
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- Organized by theme/chronology
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- Track citation counts
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### For Treatment Plans
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### For Clinical Decision Support Documents
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1. **Format Selection Based on Complexity**
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The clinical-decision-support skill supports **three document types**. Detect type from user request keywords:
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**Document Type Detection:**
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- **Individual Treatment Plan**: "treatment plan for patient", "patient with [condition]", individual case
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- **Cohort Analysis**: "cohort of N patients", "stratified by", "biomarker analysis", "patient group"
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- **Recommendation Report**: "treatment recommendations", "clinical guideline", "evidence-based", "decision algorithm"
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#### Type 1: Individual Patient Treatment Plans
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**Use When:** User requests treatment plan for a specific patient or condition
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**Format Selection Based on Complexity:**
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- **PREFERRED**: 1-page format for most cases (quick-reference card style)
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* Use `one_page_treatment_plan.tex` template
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* Dense, scannable format similar to precision oncology reports
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* Multiple comorbidities or extensive multidisciplinary interventions
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* Still maintain concise, actionable focus
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2. **Executive Summary (For Multi-Page Plans)**
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- **CRITICAL**: Include "Treatment Plan Highlights" box on first page
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- Place immediately after title, before patient information
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- Include: Key diagnosis, 2-3 primary goals, 2-3 main interventions, timeline overview
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- Use colored tcolorbox in LaTeX for visual prominence
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- Summary must fit on page 1 with patient demographics
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3. **Concise, Actionable Documentation**
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- **Default to shortest format possible**: Start with 1-page; only expand if clinical complexity requires it
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- Every sentence must add value to clinical decision-making
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- Eliminate all non-essential text and academic verbosity
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- Focus on what clinicians need to act, not comprehensive background
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- Use bullet points, tables, and structured sections for efficiency
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- Streamline: Patient Education (3-5 key points), Risk Mitigation (critical only), Expected Outcomes (2-3 statements)
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- **Minimal citations**: Use brief in-text citations only when needed (0-3 max for concise plans)
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4. **HIPAA Compliance and Safety**
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- De-identify all protected health information per Safe Harbor method
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- Remove all 18 HIPAA identifiers before sharing
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- Include critical warning signs and emergency action plans
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- Document medication safety concerns clearly
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**Key Requirements:**
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- Executive summary box on first page (diagnosis, goals, interventions, timeline)
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- Concise, actionable language (every sentence adds clinical value)
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- Bullet points, tables, structured sections
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- Minimal citations (0-3 for concise plans)
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- HIPAA de-identification (remove all 18 identifiers)
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- Emergency action plans and warning signs
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#### Type 2: Patient Cohort Analyses
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**Use When:** User requests analysis of patient groups stratified by biomarkers or characteristics
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**Template:** Use `cohort_analysis_template.tex` from clinical-decision-support skill
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**Structure (6-8 pages):**
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1. **Executive Summary** (tcolorbox)
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- Cohort size and stratification method
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- Key findings (3-5 bullet points)
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- Clinical implications (1-2 sentences)
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2. **Cohort Characteristics**
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- Patient demographics table (age, sex, ECOG PS, stage)
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- Baseline clinical features
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- Statistical comparisons between groups (p-values)
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3. **Biomarker Profile** (tcolorbox for emphasis)
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- Classification method (IHC, NGS, gene expression)
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- Group definitions with molecular features
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- Biomarker distribution and correlations
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4. **Treatment Outcomes**
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- Response rates table (ORR, CR, PR, SD, PD with 95% CI)
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- Survival outcomes (median PFS/OS, HRs, p-values)
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- Reference Kaplan-Meier curves if available
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5. **Statistical Analysis**
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- Methods section (tests used, software, significance level)
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- Multivariable Cox regression table
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- Interpretation of results
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6. **Clinical Implications** (tcolorbox with recommendations)
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- Treatment recommendations by biomarker group
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- GRADE-graded recommendations (1A, 1B, 2A, etc.)
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- Monitoring protocols
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7. **Strengths and Limitations**
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- Study strengths (3-5 points)
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- Limitations (3-5 points with impact)
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8. **References**
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- Key clinical trials, biomarker validations, guidelines
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**Statistical Reporting Standards:**
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- Report HRs with 95% CI and p-values
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- Include effect sizes, not just p-values
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- Use appropriate tests (t-test, Mann-Whitney, chi-square, log-rank)
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- Multivariable analysis adjusting for confounders
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- All p-values two-sided unless specified
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**Biomarker Nomenclature:**
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- Gene names italicized: \textit{EGFR}, \textit{KRAS}
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- HGVS notation for variants: p.L858R, c.2573T>G
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- IHC scores: 0, 1+, 2+, 3+ (HER2)
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- Expression percentages: PD-L1 TPS ≥50%
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- Specify assay method and cut-points
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#### Type 3: Treatment Recommendation Reports
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**Use When:** User requests evidence-based guidelines, treatment algorithms, or clinical pathways
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**Template:** Use `treatment_recommendation_template.tex` from clinical-decision-support skill
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**Structure (5-7 pages):**
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1. **Recommendation Strength Legend** (tcolorbox)
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- Green: STRONG (Grade 1) - benefits clearly outweigh risks
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- Yellow: CONDITIONAL (Grade 2) - trade-offs exist, shared decision-making
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- Blue: RESEARCH (Grade R) - insufficient evidence, clinical trial preferred
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- Red: NOT RECOMMENDED - evidence against use
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2. **Clinical Context**
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- Disease overview (1 paragraph)
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- Target population (inclusion/exclusion criteria)
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3. **Evidence Review**
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- Key clinical trials (design, n, results, quality)
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- Guideline concordance table (NCCN, ASCO, ESMO)
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4. **Treatment Options** (color-coded tcolorboxes by strength)
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- Option 1: STRONG (1A) - green box
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* Regimen with dosing
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* Evidence basis (trial, outcomes, guideline)
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* Indications and contraindications
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* Key toxicities and management
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* Monitoring protocol
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- Option 2: CONDITIONAL (2B) - yellow box
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* When to consider, trade-offs
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- Option 3: RESEARCH - blue box
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* Clinical trial recommendations
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5. **Clinical Decision Algorithm** (TikZ flowchart)
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- Simple pathway (5-7 decision points max)
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- Color-coded by urgency (red=urgent, yellow=semi-urgent, blue=routine)
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6. **Special Populations**
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- Elderly, renal impairment, hepatic impairment dose adjustments
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7. **Monitoring Protocol**
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- On-treatment monitoring table
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- Dose modification guidelines
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- Post-treatment surveillance schedule
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8. **References**
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- Primary trials, meta-analyses, guidelines
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**GRADE Methodology Requirements:**
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- All recommendations MUST have GRADE notation (1A, 1B, 2A, 2B, 2C)
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- Evidence quality: HIGH (⊕⊕⊕⊕), MODERATE (⊕⊕⊕○), LOW (⊕⊕○○), VERY LOW (⊕○○○)
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- Recommendation strength: STRONG ("We recommend...") vs CONDITIONAL ("We suggest...")
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- Document benefits and harms quantitatively
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- State guideline concordance (NCCN Category, ESMO Grade)
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**Color-Coded Recommendation Boxes:**
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```latex
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% Strong recommendation
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\begin{tcolorbox}[enhanced,colback=stronggreen!10,colframe=stronggreen,
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title={\textbf{RECOMMENDATION} \hfill \textbf{GRADE: 1A}}]
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We recommend [intervention] for [population]...
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\end{tcolorbox}
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% Conditional recommendation
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\begin{tcolorbox}[enhanced,colback=conditionalyellow!10,colframe=conditionalyellow,
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title={\textbf{RECOMMENDATION} \hfill \textbf{GRADE: 2B}}]
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We suggest [intervention] for patients who value [outcome]...
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\end{tcolorbox}
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```
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#### Common Elements Across All CDS Document Types
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**Professional Formatting (All Types):**
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- 0.5in margins (compact pharmaceutical style)
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- Sans-serif font (Helvetica via helvet package)
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- 10pt body text, 11pt subsections, 12-14pt headers
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- Minimal whitespace, dense information
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- Header: Document type and subject
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- Footer: "Confidential Medical Document - For Professional Use Only"
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**HIPAA Compliance (All Types):**
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- Remove all 18 HIPAA identifiers
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- Use de-identified patient IDs (PT001, PT002)
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- Aggregate data only for cohorts (no individual PHI)
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- Confidentiality notices in header/footer
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**Evidence Integration (All Types):**
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- Real citations only (verify with research-lookup)
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- NCCN, ASCO, ESMO guideline references
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- FDA approval status when relevant
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- Clinical trial data with NCT numbers
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**Statistical Rigor (Cohort and Recommendation Types):**
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- Hazard ratios with 95% CI
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- P-values (two-sided, report as p<0.001 not p=0.00)
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- Confidence intervals for all effect sizes
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- Number at risk, sample sizes clearly stated
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- Appropriate statistical tests documented
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### Progress Logging Requirements
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