CK Pharmaceutical Page 1 of 2
Protocol 3001
Example 1
Subject Characteristics at Study Entry
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Treatment Regimen: BID Treatment Regimen: TID
_____________________________________________________ _____________________________________________________
Treatment A Treatment B Total Treatment A Treatment B Total
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Gender
Male 31/ 52 (59.6%) 32/ 53 (60.4%) 63/105 (60.0%) 8/ 11 (72.7%) 5/ 7 (71.4%) 13/ 18 (72.2%)
Female 21/ 52 (40.4%) 21/ 53 (39.6%) 42/105 (40.0%) 3/ 11 (27.3%) 2/ 7 (28.6%) 5/ 18 (27.8%)
Race
White 40/ 52 (76.9%) 42/ 53 (79.2%) 82/105 (78.1%) 10/ 11 (90.9%) 6/ 7 (85.7%) 16/ 18 (88.9%)
Black 10/ 52 (19.2%) 9/ 53 (17.0%) 19/105 (18.1%) 1/ 11 (9.1%) 1/ 7 (14.3%) 2/ 18 (11.1%)
Asian/Oriental 2/ 52 (3.8%) 1/ 53 (1.9%) 3/105 (2.9%) 0/ 11 (0.0%) 0/ 7 (0.0%) 0/ 18 (0.0%)
Multiracial 0/ 52 (0.0%) 1/ 53 (1.9%) 1/105 (1.0%) 0/ 11 (0.0%) 0/ 7 (0.0%) 0/ 18 (0.0%)
Age (years)
N 52 53 105 11 7 18
Mean 62.12 58.43 60.26 51.09 54.43 52.39
SD 8.661 8.632 8.801 10.483 8.848 9.751
Median 59.50 58.00 59.00 50.00 52.00 51.00
Min 43.00 44.00 43.00 38.00 42.00 38.00
Max 80.00 79.00 80.00 72.00 64.00 72.00
Height (cm)
N 52 53 105 11 7 18
Mean 171.56 171.75 171.66 178.10 179.23 178.54
SD 11.826 12.612 12.171 12.559 5.749 10.235
Median 172.45 170.20 171.50 177.80 179.80 178.80
Min 142.20 147.30 142.20 160.00 171.50 160.00
Max 207.00 203.20 207.00 193.00 186.20 193.00
__________________________________________________________________________________________________________________________________
Note: Age was calculated by ((date of consent-date of birth)/365.25); BMI was calculated by (weight(kg)/height(m)**2).
Data are simulated and do not represent any actual trials.
Pgm: G:\caz\xprint\example1.sas Runtime: 11MAY2007 12:58 PM Validated: Yes
CK Pharmaceutical Page 2 of 2
Protocol 3001
Example 1
Subject Characteristics at Study Entry
__________________________________________________________________________________________________________________________________
Treatment Regimen: BID Treatment Regimen: TID
_____________________________________________________ _____________________________________________________
Treatment A Treatment B Total Treatment A Treatment B Total
__________________________________________________________________________________________________________________________________
Weight (kg)
N 52 53 105 11 7 18
Mean 99.66 105.44 102.58 114.98 104.63 110.96
SD 23.222 20.790 22.113 25.470 13.543 21.755
Median 98.85 104.10 102.00 117.00 105.40 109.55
Min 54.10 66.00 54.10 67.70 88.90 67.70
Max 167.40 175.30 175.30 157.90 125.60 157.90
BMI (kg/m^2)
N 52 53 105 11 7 18
Mean 33.89 35.96 34.94 36.73 32.47 35.07
SD 7.306 7.046 7.217 9.329 2.779 7.647
Median 32.99 35.56 33.56 38.77 33.34 34.01
Min 18.96 24.21 18.96 21.42 27.95 21.42
Max 56.88 55.29 56.88 50.26 36.23 50.26
__________________________________________________________________________________________________________________________________
Note: Age was calculated by ((date of consent-date of birth)/365.25); BMI was calculated by (weight(kg)/height(m)**2).
Data are simulated and do not represent any actual trials.
Pgm: G:\caz\xprint\example1.sas Runtime: 11MAY2007 12:58 PM Validated: Yes
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