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1. Summary of Demographics
  Output: Out14-1-1 (- Summary of Demographics)
    Documentation:
      > Clinical Study Report (./csr-cdiscpilot01.pdf)
          - Pages 46-48 [Table 14-2.01]
    Categories:
      > Population Description
      > Demographics
    Output File(s):
      > RTF Format: t14-1-1-demog (RTF) (./t14-1-1-demog.rtf)
      > PDF Format: t14-1-1-demog (PDF) (./t14-1-1-demog.pdf)
    Displays:
      1. Disp14-1-1 - Demographics (Demog)
        Display Title: Summary of Demographics
        Sections:
          > Header:
            1. Study - CDISC 360
            2. Page x of y
          > Title:
            1. Table 14.1.1
            2. Summary of Demographics
            3. Safety Population
          > FootnoteFooter:
            1. Source dataset: adsl, Generated on: DDMONYYYY:HH:MM
            2. Program: <pid>.sas, Output: <pid><oid>.rtf, Generated on: DDMONYYYY:HH:MM
          > Rowlabel Header:
            1. Characteristics
  1.1. Summary of Subjects by Treatment
    Analysis: An01_05_SAF_Summ_ByTrt (- Summary of Subjects by Treatment)
      Documentation:
        Reason: SPECIFIED IN SAP
        Purpose: PRIMARY OUTCOME MEASURE
        See:
          > Statistical Analysis Plan (./sap.pdf)
            - Page 9 [6. ANALYSIS POPULATIONS]
      Categories:
        > Population Description
        > Subject-level
        > Demographics
      Population: Safety Population [ADSL.AnalysisSet_02_SAF - Safety Population (SAF)
        Selection Criteria: ADSL.SAFFL EQ 'Y']
      Groupings:
        1. AnlsGrouping_01_Trt - Treatment
          Grouping Variable: ADSL.TRT01A
          Groups [Results per group: Y]:
           1. Placebo [  1. AnlsGrouping_01_Trt_1 - Placebo
               Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
           3.   3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
               Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
      Analysis Variable: ADSL.USUBJID
      Method: Mth01_CatVar_Count_ByGrp - Count by group for a categorical variable (Grouped count for categorical variable)
              Count across groups for a categorical variable, based on subject occurrence
        Operations:
          > 1. Mth01_CatVar_Count_ByGrp_1_n : - Count of subjects (n)
  1.2. Age
    1.2.1. Summary by Treatment
      Analysis: An03_01_Age_Summ_ByTrt (- Summary of Age by Treatment (Age)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: Y]:
             1. Placebo [  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2.   2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3. Xanomeline High Dose [  3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
        Analysis Variable: ADSL.AGE
        Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
                Descriptive summary statistics across groups for a continuous variable
          Operations:
            > 1. Mth02_ContVar_Summ_ByGrp_1_n : - Count of non-missing values (n)
            > 2. Mth02_ContVar_Summ_ByGrp_2_Mean : - Mean (Mean)
            > 3. Mth02_ContVar_Summ_ByGrp_3_SD : - Standard deviation (SD)
            > 4. Mth02_ContVar_Summ_ByGrp_4_Median : - Median (Median)
            > 5. Mth02_ContVar_Summ_ByGrp_5_Q1 : - First quartile (Q1)
            > 6. Mth02_ContVar_Summ_ByGrp_6_Q3 : - Third quartile (Q3)
            > 7. Mth02_ContVar_Summ_ByGrp_7_Min : - Minimum (Min)
            > 8. Mth02_ContVar_Summ_ByGrp_8_Max : - Maximum (Max)
    1.2.2. Comparison by Treatment
      Analysis: An03_01_Age_Comp_ByTrt (- Comparison of Age by Treatment (Age)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']
        Groupings:
          1. Treatment [Results per group: N]:AnlsGrouping_01_Trt - Treatment
             1. Placebo [Grouping Variable: ADSL.TRT01A EQ 'Placebo']
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']Groups [Results per group: N]:
             3. Xanomeline High Dose [  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High DosePlacebo']
        Analysis Variable: ADSL.AGE      2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
        Method: Analysis of variance group comparison for a continuous variable
          Operations: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
            > Mth04_ContVar_Comp_Anova_1_pval: P-value (p-value)
  1.3. Age Group
    1.3.1. Summary of Subjects by Treatment
      Analysis: An03_02_AgeGrp_Summ_ByTrt (Summary of Subjects by Treatment and Age Group)
        Documentation:  3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
          Reason: SPECIFIED IN SAPAnalysis Variable: ADSL.AGE
          Purpose: PRIMARY OUTCOME MEASUREMethod: Mth04_ContVar_Comp_Anova - Analysis of variance group comparison for a continuous variable (ANOVA group comparison for continuous variable)
          See:
            > Statistical Analysis Plan (./sap.pdf)Comparison of groups by analysis of variance (ANOVA) for a continuous variable
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        CategoriesOperations:
          > Population Description
          > Subject-level
          > Demographics1. Mth04_ContVar_Comp_Anova_1_pval - P-value (p-value)
  1.3. Age Group
    1.3.1. Summary of Subjects by Treatment
        Population: Safety Population [ADSL.SAFFL EQ 'Y']Analysis: An03_02_AgeGrp_Summ_ByTrt - Summary of Subjects by Treatment and Age Group (Age Group)
        GroupingsDocumentation:
          1. Treatment [Results per group: Y]:Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
             1. Placebo [ADSL.TRT01A EQ 'Placebo']See:
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
> Statistical Analysis Plan (./sap.pdf)
               3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose'- Page 13 [9.2. Demographic and Baseline Characteristics]
          2. Age Group [Results per group: Y]Categories:
             1. < 65 years [ADSL.AGEGR1 EQ '<65']> Population Description
             2. ≥ 65 years [ADSL.AGEGR1 IN ('65-80', '>80')]> Subject-level
        Analysis Variable: ADSL.USUBJID  > Demographics
        Method: Summary by group of a categorical variablePopulation: AnalysisSet_02_SAF - Safety Population (SAF)
          Operations:Selection Criteria: ADSL.SAFFL EQ 'Y'
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)Groupings:
            > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)1. AnlsGrouping_01_Trt - Treatment
              - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysisGrouping Variable: ADSL.TRT01A
              - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    1.3.2. Comparison of Subjects by Treatment
      Analysis: An03_02_AgeGrp_Comp_ByTrt (Comparison of Age Group by Treatment)Groups [Results per group: Y]:
              1. AnlsGrouping_01_Trt_1 - Placebo
        Documentation:
          Reason: SPECIFIED IN SAP Selection Criteria: ADSL.TRT01A EQ 'Placebo'
          Purpose: PRIMARY OUTCOME MEASURE
    2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
      See:
            > Statistical Analysis Plan (./sap.pdf) Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
              - Page 13 [9.2. Demographic and Baseline Characteristics]3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
        Categories:         Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
          > Population Description
2. AnlsGrouping_03_AgeGp - Age Group
            > Subject-levelGrouping Variable: ADSL.AGEGR1
          > Demographics
        Population: Safety Population [ADSL.SAFFL EQ 'Y']  Groups [Results per group: Y]:
        Groupings:
          1. Treatment [Results per group: N]:1. AnlsGrouping_03_AgeGp_1 - < 65 years
             1. Placebo [     Selection Criteria: ADSL.TRT01A AGEGR1 EQ 'Placebo<65']
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']  2. AnlsGrouping_03_AgeGp_2 - ≥ 65 years
             3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']     Selection Criteria: ADSL.AGEGR1 IN ('65-80', '>80')
          2. Age Group [Results per group: N]:Analysis Variable: ADSL.USUBJID
             1. < 65 years [ADSL.AGEGR1 EQ '<65']
             2. ≥ 65 years [ADSL.AGEGR1 IN ('65-80', '>80')]Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
        Analysis Variable: ADSL.USUBJID
        Method: Pearson's chi-square test group comparison Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
            > Mth031. Mth01_CatVar_CompSumm_PChiSqByGrp_1_pval: P-value (p-valuen - Count of subjects (n)
  1.4. Sex
    1.4.1. Summary of Subjects by Treatment
      Analysis: An03_03_Sex_Summ_ByTrt (Summary of Subjects by Treatment and Sex)
        Documentation:
2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
                Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
                See:
            > Statistical Analysis Plan (./sap.pdf- Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    1.3.2. Comparison of Subjects by Treatment
      Analysis: An03_02_AgeGrp_Comp_ByTrt - Comparison of Age Group by Treatment (Age Group)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']
        Groupings:
          1. Treatment [Results AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: YN]:
             1. Placebo [  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2. Xanomeline Low Dose [ADSL.TRT01A EQ '  2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose']
             3. Xanomeline High Dose [     Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Low Dose']
          2. Gender [Results per group: Y]:
    3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 1. Male [ Selection Criteria: ADSL.SEX TRT01A EQ 'MXanomeline High Dose']
             2. Female [ADSL.SEX EQ 'F']2. AnlsGrouping_03_AgeGp - Age Group
        Analysis     Grouping Variable: ADSL.USUBJIDAGEGR1
            Method: Summary by group of a categorical variableGroups [Results per group: N]:
          Operations:    1. AnlsGrouping_03_AgeGp_1 - < 65 years
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)
     Selection Criteria: ADSL.AGEGR1 EQ '<65'
              > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%)2. AnlsGrouping_03_AgeGp_2 - ≥ 65 years
              - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis   Selection Criteria: ADSL.AGEGR1 IN ('65-80', '>80')
        Analysis Variable: ADSL.USUBJID
        Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
                Comparison of groups by Pearson's chi-square test for a categorical variable
          Operations:
            1. Mth03_CatVar_Comp_PChiSq_1_pval - P-value (p-value)
  1.4. Sex
    1.4.1. Summary of Subjects by Treatment
      Analysis: An03_03_Sex_Summ_ByTrt - Summary of Subjects by Treatment and Sex (Sex)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: Y]:
              1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo'
              2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
              3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
          2. AnlsGrouping_02_Sex - Gender
            Grouping Variable: ADSL.SEX
            Groups [Results per group: Y]:
              1. AnlsGrouping_02_Sex_1 - Male
                 Selection Criteria: ADSL.SEX EQ 'M'
              2. AnlsGrouping_02_Sex_2 - Female
                 Selection Criteria: ADSL.SEX EQ 'F'
        Analysis Variable: ADSL.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
                Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
            1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
            2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
                - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
                - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    1.4.2. Comparison of Subjects by Treatment
      Analysis: An03_03_Sex_Comp_ByTrt - Comparison of Sex by Treatment (Sex)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
              1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo'
              2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
              3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
          2. AnlsGrouping_02_Sex - Gender
            Grouping Variable: ADSL.SEX
            Groups [Results per group: N]:
              1. AnlsGrouping_02_Sex_1 - Male
                 Selection Criteria: ADSL.SEX EQ 'M'
              2. AnlsGrouping_02_Sex_2 - Female
                 Selection Criteria: ADSL.SEX EQ 'F'
        Analysis Variable: ADSL.USUBJID
        Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
                Comparison of groups by Pearson's chi-square test for a categorical variable
          Operations:
            1. Mth03_CatVar_Comp_PChiSq_1_pval - P-value (p-value)
  1.5. Ethnicity
    1.5.1. Summary of Subjects by Treatment
      Analysis: An03_04_Ethnic_Summ_ByTrt - Summary of Subjects by Treatment and Ethnicity (Ethnicity)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y'
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: Y]:
              - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    1.4.2. Comparison of Subjects by Treatment
      Analysis: An03_03_Sex_Comp_ByTrt (Comparison of Sex by Treatment)
        Documentation:1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo'
              2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
          Reason: SPECIFIED IN SAP
    3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
      Purpose: PRIMARY OUTCOME MEASURE
          See: Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
            > Statistical Analysis Plan (./sap.pdf)2. AnlsGrouping_05_Ethnic - Ethnicity
              - Page 13 [9.2. Demographic and Baseline Characteristics]Grouping Variable: ADSL.ETHNIC
        Categories    Groups [Results per group: Y]:
          > Population Description
          > Subject-level    1. AnlsGrouping_05_Ethnic_1 - Hispanic or Latino
          > Demographics
        Population: Safety Population [ Selection Criteria: ADSL.SAFFL ETHNIC EQ 'YHISPANIC OR LATINO']
        Groupings:
          1. Treatment [Results per group: N]:
      2. AnlsGrouping_05_Ethnic_2 - Not Hispanic or Latino
                 1. Placebo [ Selection Criteria: ADSL.TRT01A ETHNIC EQ 'PlaceboNOT HISPANIC OR LATINO']
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. Gender [Results per group: N]:Analysis Variable: ADSL.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
                Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
             1. Male [ADSL.SEX EQ 'M']Operations:
             2. Female [ADSL.SEX EQ 'F']
1. Mth01_CatVar_Summ_ByGrp_1_n - Count of subjects (n)
            Analysis Variable: ADSL.USUBJID2. Mth01_CatVar_Summ_ByGrp_2_pct - Percent of subjects (%)
        Method: Pearson's chi-square test group comparison for a categorical variable
          Operations:
- Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
                > Mth03_CatVar_Comp_PChiSq_1_pval: P-value (p-value)
  1.5. Ethnicity
    - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    1.5.12. Summary Comparison of Subjects by Treatment
      Analysis: An03_04_Ethnic_SummComp_ByTrt (Summary - Comparison of Subjects Ethnicity by Treatment and (Ethnicity)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']

        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            GroupingsGrouping Variable: ADSL.TRT01A
          1. Treatment   Groups [Results per group: YN]:
               1. Placebo [1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
               2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
               3. Xanomeline High Dose [3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. AnlsGrouping_05_Ethnic - Ethnicity
            Grouping Variable: ADSL.ETHNIC
            Groups [Results per group: YN]:
               1. 1. AnlsGrouping_05_Ethnic_1 - Hispanic or Latino [
                 Selection Criteria: ADSL.ETHNIC EQ 'HISPANIC OR LATINO']
               2. 2. AnlsGrouping_05_Ethnic_2 - Not Hispanic or Latino [
                 Selection Criteria: ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO']
        Analysis Variable: ADSL.USUBJID
        Method: Summary by group of a categorical variable
          Operations:
            > Mth01_CatVar_Summ_ByGrp_1_n: Count of subjects (n)
            > Mth01_CatVar_Summ_ByGrp_2_pct: Percent of subjects (%Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
              - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis  Comparison of groups by Pearson's chi-square test for a categorical variable
              - Denominator: result of operation Mth01Operations:
            1. Mth03_CatVar_CountComp_ByGrpPChiSq_1_n for analysis An01_05_SAF_Summ_ByTrtpval - P-value (p-value)
  1.6. Race
    1.56.21. Comparison Summary of Subjects by Treatment
      Analysis: An03_0405_EthnicRace_CompSumm_ByTrt (Comparison - Summary of Ethnicity Subjects by Treatment and Race (Race)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [ADSL.SAFFL EQ 'Y']
        Groupings:
          1. Treatment [Results per group: N]Categories:
             1. Placebo [ADSL.TRT01A EQ 'Placebo']> Population Description
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']> Subject-level
             3. Xanomeline High Dose [ADSL.TRT01A EQ 'Xanomeline High Dose']> Demographics
          2. Ethnicity [Results per group: N]:Population: AnalysisSet_02_SAF - Safety Population (SAF)
             1. Hispanic or Latino [Selection Criteria: ADSL.ETHNIC SAFFL EQ 'HISPANIC OR LATINOY']
        Groupings:
     2. Not Hispanic or Latino [ADSL.ETHNIC EQ 'NOT HISPANIC OR LATINO']
      1. AnlsGrouping_01_Trt - Treatment
            Analysis Grouping Variable: ADSL.USUBJIDTRT01A
        Method: Pearson's chi-square test group comparison for a categorical variable
          Operations    Groups [Results per group: Y]:
            > Mth03_CatVar_Comp_PChiSq_1_pval: P-value (p-value)
  1.6. Race
    1.6.1. Summary of Subjects by Treatment
      Analysis: An03_05_Race_Summ_ByTrt (Summary of Subjects by Treatment and Race)
        Documentation:
          Reason: SPECIFIED IN SAP  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo'
              2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'
              3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
          Purpose: PRIMARY OUTCOME MEASURE       Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose'
          See:2. AnlsGrouping_04_Race - Primary Race
            > Statistical Analysis Plan (./sap.pdf)Grouping Variable: ADSL.RACE
              - Page 13 [9.2. Demographic and Baseline Characteristics]Groups [Results per group: Y]:
        Categories:      1. AnlsGrouping_04_Race_1 - American Indian or Alaska Native
          > Population Description       Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE'
          > Subject-level    2. AnlsGrouping_04_Race_2 - Asian
          > Demographics
        Population: Safety Population [ Selection Criteria: ADSL.SAFFL RACE EQ 'YASIAN']
        Groupings:
          1. Treatment [Results per group: Y]:
3. AnlsGrouping_04_Race_3 - Black or African American
                 1. Placebo [ Selection Criteria: ADSL.TRT01A RACE EQ 'PlaceboBLACK OR AFRICAN AMERICAN']
             2. Xanomeline Low Dose [ADSL.TRT01A EQ 'Xanomeline Low Dose']
  4. AnlsGrouping_04_Race_4 - Native Hawaiian or Other Pacific Islander
                 3. Xanomeline High Dose [ Selection Criteria: ADSL.TRT01A RACE EQ 'Xanomeline High Dose']NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER'
          2. Primary Race [Results per group: Y]:    5. AnlsGrouping_04_Race_5 - White
             1. American Indian or Alaska Native [     Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVEWHITE']
             2. Asian [  6. AnlsGrouping_04_Race_6 - Multiple
                 Selection Criteria: ADSL.RACE EQ 'ASIANMULTIPLE']
             3. Black or African American [ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN']  7. AnlsGrouping_04_Race_7 - Not Reported
             4. Native Hawaiian or Other Pacific Islander [     Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']
NOT REPORTED'
               5. White [ADSL.RACE EQ 'WHITE']
8. AnlsGrouping_04_Race_8 - Unknown
               6. Multiple [   Selection Criteria: ADSL.RACE EQ 'MULTIPLEUNKNOWN']
             7. Not Reported [ADSL.RACE EQ 'NOT REPORTED']  9. AnlsGrouping_04_Race_9 - Other
             8. Unknown [     Selection Criteria: ADSL.RACE EQ 'UNKNOWNOTHER']
             9. Other [ADSL.RACE EQ 'OTHER']Analysis Variable: ADSL.USUBJID
        Method: Mth01_CatVar_Summ_ByGrp - Summary by group of a categorical variable (Grouped summary of categorical variable)
        Analysis Variable: ADSL.USUBJID
        Method: Summary by group of Descriptive summary statistics across groups for a categorical variable, based on subject occurrence
          Operations:
            > 1. Mth01_CatVar_Summ_ByGrp_1_n : - Count of subjects (n)
            > 2. Mth01_CatVar_Summ_ByGrp_2_pct : - Percent of subjects (%)
                - Numerator: result of operation Mth01_CatVar_Summ_ByGrp_1_n for this analysis
                - Denominator: result of operation Mth01_CatVar_Count_ByGrp_1_n for analysis An01_05_SAF_Summ_ByTrt
    1.6.2. Comparison of Subjects by Treatment
      Analysis: An03_05_Race_Comp_ByTrt (- Comparison of Race by Treatment (Race)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']

        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
          Groupings:  Grouping Variable: ADSL.TRT01A
          1. Treatment   Groups [Results per group: N]:
               1. Placebo [1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
               2. 2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose'Xanomeline Low Dose']

              3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose
               3. Xanomeline High Dose [   Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
          2. AnlsGrouping_04_Race - Primary Race
            Grouping Variable: ADSL.RACE
            Groups [Results per group: N]:
             1.   1. AnlsGrouping_04_Race_1 - American Indian or Alaska Native [
                 Selection Criteria: ADSL.RACE EQ 'AMERICAN INDIAN OR ALASKA NATIVE']ALASKA NATIVE'
              2. AnlsGrouping_04_Race_2 - Asian
             2. Asian [     Selection Criteria: ADSL.RACE EQ 'ASIAN']
             3.   3. AnlsGrouping_04_Race_3 - Black or African American [
                 Selection Criteria: ADSL.RACE EQ 'BLACK OR AFRICAN AMERICAN']
             4.   4. AnlsGrouping_04_Race_4 - Native Hawaiian or Other Pacific Islander [
                 Selection Criteria: ADSL.RACE EQ 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER']PACIFIC ISLANDER'
              5. AnlsGrouping_04_Race_5 - White
             5. White [     Selection Criteria: ADSL.RACE EQ 'WHITE']
             6. Multiple [  6. AnlsGrouping_04_Race_6 - Multiple
                 Selection Criteria: ADSL.RACE EQ 'MULTIPLE']
             7. Not Reported [  7. AnlsGrouping_04_Race_7 - Not Reported
                 Selection Criteria: ADSL.RACE EQ 'NOT REPORTED']

              8. AnlsGrouping_04_Race_8 - Unknown
                 8. Unknown [ Selection Criteria: ADSL.RACE EQ 'UNKNOWN']
               9. Other [9. AnlsGrouping_04_Race_9 - Other
                 Selection Criteria: ADSL.RACE EQ 'OTHER']
        Analysis Variable: ADSL.USUBJID
        Method: Method: Mth03_CatVar_Comp_PChiSq - Pearson's chi-square test group comparison for a categorical variable (Pearson's chi-square test group comparison for categorical variable)
                Comparison of groups by Pearson's chi-square test group comparison for a categorical variable
          Operations:
            > 1. Mth03_CatVar_Comp_PChiSq_1_pval : - P-value (p-value)
  1.7. Height
    1.7.1. Summary by Treatment
      Analysis: An03_06_Height_Summ_ByTrt (- Summary of Height by Treatment (Height)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: Safety Population [AnalysisSet_02_SAF - Safety Population (SAF)
          Selection Criteria: ADSL.SAFFL EQ 'Y']
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: Y]:
             1. Placebo [  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']
             2.   2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3.   3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
        Analysis Variable: ADSL.HEIGHTBL
HEIGHTBL
        Method: Mth02_ContVar_Summ_ByGrp - Summary by group of a continuous variable (Grouped summary of continuous variable)
                Method: Summary by group of Descriptive summary statistics across groups for a continuous variable
          Operations:
            > 1. Mth02_ContVar_Summ_ByGrp_1_n : - Count of non-missing values (n)
            > 2. Mth02_ContVar_Summ_ByGrp_2_Mean : - Mean (Mean)
            > 3. Mth02_ContVar_Summ_ByGrp_3_SD : - Standard deviation (SD)
            > 4. Mth02_ContVar_Summ_ByGrp_4_Median : - Median (Median)
            > 5. Mth02_ContVar_Summ_ByGrp_5_Q1 : - First quartile (Q1)
            > 6. Mth02_ContVar_Summ_ByGrp_6_Q3 : - Third quartile (Q3)
            > 7. Mth02_ContVar_Summ_ByGrp_7_Min : - Minimum (Min)
            > 8. Mth02_ContVar_Summ_ByGrp_8_Max : - Maximum (Max)
    1.7.2. Comparison by Treatment
      Analysis: An03_06_Height_Comp_ByTrt (- Comparison of Height by Treatment (Height)
        Documentation:
          Reason: SPECIFIED IN SAP
          Purpose: PRIMARY OUTCOME MEASURE
          See:
            > Statistical Analysis Plan (./sap.pdf)
              - Page 13 [9.2. Demographic and Baseline Characteristics]
        Categories:
          > Population Description
          > Subject-level
          > Demographics
        Population: AnalysisSet_02_SAF - Safety Population (SAF)
          > Demographics
        Population: Safety Population [Selection Criteria: ADSL.SAFFL EQ 'Y']
        Groupings:
          1. AnlsGrouping_01_Trt - Treatment
            Grouping Variable: ADSL.TRT01A
            Groups [Results per group: N]:
             1. Placebo [  1. AnlsGrouping_01_Trt_1 - Placebo
                 Selection Criteria: ADSL.TRT01A EQ 'Placebo']'
              2. AnlsGrouping_01_Trt_2 - Xanomeline Low Dose
             2. Xanomeline Low Dose [     Selection Criteria: ADSL.TRT01A EQ 'Xanomeline Low Dose']
             3.   3. AnlsGrouping_01_Trt_3 - Xanomeline High Dose [
                 Selection Criteria: ADSL.TRT01A EQ 'Xanomeline High Dose']
        Analysis Variable: ADSL.HEIGHTBL
        Method: Mth04_ContVar_Comp_Anova - Analysis of variance group comparison for a continuous variable (ANOVA group comparison for continuous variable)
                Comparison of groups by analysis of variance (ANOVA) for a continuous variable
          Operations:
            > 1. Mth04_ContVar_Comp_Anova_1_pval : - P-value (p-value)