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The Pilot 1 Team generated the below output using R and it was delivered to the FDA. You can find the source code that generated this output here and a deeper dive of the process here. We delivered the identical output with the R generated ADaM.

## Protocol: CDISCPILOT01
## Population: Intent-to-Treat
## 
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##                                          Placebo       Xanomeline Low Dose   Xanomeline High Dose
##                                          (N=86)              (N=84)                 (N=84)       
## —————————————————————————————————————————————————————————————————————————————————————————————————
## Age                                                                                              
##   Mean (sd)                           75.21 (8.59)        75.67 (8.29)           74.38 (7.89)    
##   Median                                  76.00               77.50                 76.00        
##   Min - Max                           52.00 - 89.00       51.00 - 88.00         56.00 - 88.00    
## Pooled Age Group 1                                                                               
##   <65                                      14                   8                     11         
##   65-80                                    42                  47                     55         
##   >80                                      30                  29                     18         
## Race                                                                                             
##   WHITE                                    78                  78                     74         
##   BLACK OR AFRICAN AMERICAN                 8                   6                     9          
##   AMERICAN INDIAN OR ALASKA NATIVE          0                   0                     1          
## Baseline Height (cm)                                                                             
##   Mean (sd)                          162.57 (11.52)      163.43 (10.42)         165.82 (10.13)   
##   Median                                 162.60              162.60                 165.10       
##   Min - Max                          137.20 - 185.40     135.90 - 195.60       146.10 - 190.50   
## Baseline Weight (kg)                                                                             
##   Mean (sd)                           62.76 (12.77)       67.28 (14.12)         70.00 (14.65)    
##   Median                                  60.55               64.90                 69.20        
##   Min - Max                           34.00 - 86.20      45.40 - 106.10         41.70 - 108.00   
## Baseline BMI (kg/m^2)                                                                            
##   Mean (sd)                           23.64 (3.67)        25.06 (4.27)           25.35 (4.16)    
##   Median                                  23.40               24.30                 24.80        
##   Min - Max                           15.10 - 33.30       17.70 - 40.10         13.70 - 34.50    
## MMSE Total                                                                                       
##   Mean (sd)                           18.05 (4.27)        17.87 (4.22)           18.51 (4.16)    
##   Median                                  19.50               18.00                 20.00        
##   Min - Max                           10.00 - 23.00       10.00 - 24.00         10.00 - 24.00    
## —————————————————————————————————————————————————————————————————————————————————————————————————
## 
## Program: tlf_demographic.Rmd 
## 2024-05-30 18:10:11