                                                Listing 1.0
                                                ADSL Dataset

USUBJID    STUDYID SUBJID SITEID AGE AGEU  AGEGR1      SEX RACE                      RACEN
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 BBC     041        10  44 YEARS 40-49 years F   WHITE                         5

BBC-10-042 BBC     042        10  25 YEARS 18-29 years F   WHITE                         5
BBC-10-043 BBC     043        10  24 YEARS 18-29 years F   WHITE                         5
BBC-10-145 BBC     145        10  31 YEARS 30-39 years M   UNKNOWN                       6

BBC-10-146 BBC     146        10  29 YEARS 18-29 years M   WHITE                         5
BBC-10-147 BBC     147        10  52 YEARS 50-65 years M   BLACK OR AFRICAN AMERICAN     4
BBC-10-148 BBC     148        10  43 YEARS 40-49 years M   WHITE                         5
BBC-10-149 BBC     149        10  57 YEARS 50-65 years M   BLACK OR AFRICAN AMERICAN     4
BBC-10-150 BBC     150        10  25 YEARS 18-29 years M   WHITE                         5
BBC-10-151 BBC     151        10  66 YEARS >65 years   M   WHITE                         5
BBC-10-152 BBC     152        10  63 YEARS 50-65 years M   WHITE                         5
BBC-11-048 BBC     048        11  38 YEARS 30-39 years F   ASIAN                         2
BBC-11-093 BBC     093        11  52 YEARS 50-65 years M   WHITE                         5
BBC-11-094 BBC     094        11  40 YEARS 40-49 years M   WHITE                         5
BBC-11-095 BBC     095        11  62 YEARS 50-65 years M   WHITE                         5
BBC-11-096 BBC     096        11  53 YEARS 50-65 years M   WHITE                         5

BBC-11-097 BBC     097        11  24 YEARS 18-29 years F   WHITE                         5

BBC-11-098 BBC     098        11  67 YEARS >65 years   M   WHITE                         5
BBC-11-099 BBC     099        11  64 YEARS 50-65 years M   WHITE                         5
BBC-11-100 BBC     100        11  30 YEARS 30-39 years F   WHITE                         5

BBC-12-057 BBC     057        12  25 YEARS 18-29 years F   WHITE                         5

BBC-12-058 BBC     058        12  75 YEARS >65 years   F   WHITE                         5
BBC-12-059 BBC     059        12  40 YEARS 40-49 years F   WHITE                         5

BBC-12-060 BBC     060        12  62 YEARS 50-65 years F   BLACK OR AFRICAN AMERICAN     4
BBC-12-061 BBC     061        12  47 YEARS 40-49 years F   WHITE                         5

BBC-12-062 BBC     062        12  70 YEARS >65 years   M   WHITE                         5
BBC-12-063 BBC     063        12  65 YEARS 50-65 years F   WHITE                         5
BBC-13-025 BBC     025        13  24 YEARS 18-29 years M   WHITE                         5

BBC-13-026 BBC     026        13  51 YEARS 50-65 years F   WHITE                         5

Time                                                                                            Page 1 of 36
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                                                ADSL Dataset

USUBJID    ETHNIC                 ETHNICN COUNTRY ARM   ACTARM TRT01P TRT01PN TRT01A TRT01AN TRTSDT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 HISPANIC OR LATINO           1         ARM B        ARM B        2 ARM B        2

BBC-10-042 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 10JAN2007
BBC-10-043 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 09FEB2007
BBC-10-145 HISPANIC OR LATINO           1         ARM A        ARM A        1 ARM A        1 08DEC2006

BBC-10-146 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 11DEC2006
BBC-10-147 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 12DEC2006
BBC-10-148 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 12DEC2006
BBC-10-149 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 13DEC2006
BBC-10-150 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 14DEC2006
BBC-10-151 HISPANIC OR LATINO           1         ARM B        ARM B        2 ARM B        2 28DEC2006
BBC-10-152 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 08JAN2007
BBC-11-048 UNKNOWN                      3         ARM B        ARM B        2 ARM B        2 18JAN2007
BBC-11-093 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 08NOV2006
BBC-11-094 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 08NOV2006
BBC-11-095 HISPANIC OR LATINO           1         ARM C        ARM C        3 ARM C        3 10NOV2006
BBC-11-096 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 27NOV2006

BBC-11-097 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 28NOV2006

BBC-11-098 HISPANIC OR LATINO           1         ARM C        ARM C        3 ARM C        3 04DEC2006
BBC-11-099 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 08DEC2006
BBC-11-100 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 11JAN2007

BBC-12-057 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 14NOV2006

BBC-12-058 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 15NOV2006
BBC-12-059 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 17NOV2006

BBC-12-060 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 06DEC2006
BBC-12-061 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 04JAN2007

BBC-12-062 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 15JAN2007
BBC-12-063 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 23JAN2007
BBC-13-025 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 24OCT2006

BBC-13-026 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 02NOV2006

Time                                                                                            Page 2 of 36
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                                                ADSL Dataset

USUBJID    TRTEDT    TRTDURN TRTDURU TR01SDT   TR01EDT   INCNFL RANDFL RANDEXC1 RANDEXC2 RANDEXC3 RANDEXC4
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041                                               Y      Y

BBC-10-042 13APR2007      94 DAY     10JAN2007 13APR2007 Y      Y
BBC-10-043 03MAY2007      84 DAY     09FEB2007 03MAY2007 Y      Y
BBC-10-145 30MAR2007     113 DAY     08DEC2006 30MAR2007 Y      Y

BBC-10-146 16MAR2007      96 DAY     11DEC2006 16MAR2007 Y      Y
BBC-10-147 18MAR2007      97 DAY     12DEC2006 18MAR2007 Y      Y
BBC-10-148 07MAR2007      86 DAY     12DEC2006 07MAR2007 Y      Y
BBC-10-149 13MAR2007      91 DAY     13DEC2006 13MAR2007 Y      Y
BBC-10-150 13MAR2007      90 DAY     14DEC2006 13MAR2007 Y      Y
BBC-10-151 22MAR2007      85 DAY     28DEC2006 22MAR2007 Y      Y
BBC-10-152 04APR2007      87 DAY     08JAN2007 04APR2007 Y      Y
BBC-11-048 09APR2007      82 DAY     18JAN2007 09APR2007 Y      Y
BBC-11-093 31JAN2007      85 DAY     08NOV2006 31JAN2007 Y      Y
BBC-11-094 06FEB2007      91 DAY     08NOV2006 06FEB2007 Y      Y
BBC-11-095 31JAN2007      83 DAY     10NOV2006 31JAN2007 Y      Y
BBC-11-096 05MAR2007      99 DAY     27NOV2006 05MAR2007 Y      Y

BBC-11-097 20FEB2007      85 DAY     28NOV2006 20FEB2007 Y      Y

BBC-11-098 26FEB2007      85 DAY     04DEC2006 26FEB2007 Y      Y
BBC-11-099 02MAR2007      85 DAY     08DEC2006 02MAR2007 Y      Y
BBC-11-100 03APR2007      83 DAY     11JAN2007 03APR2007 Y      Y

BBC-12-057                           14NOV2006           Y      Y

BBC-12-058 06FEB2007      84 DAY     15NOV2006 06FEB2007 Y      Y
BBC-12-059 07FEB2007      83 DAY     17NOV2006 07FEB2007 Y      Y

BBC-12-060 27FEB2007      84 DAY     06DEC2006 27FEB2007 Y      Y
BBC-12-061 27MAR2007      83 DAY     04JAN2007 27MAR2007 Y      Y

BBC-12-062 08APR2007      84 DAY     15JAN2007 08APR2007 Y      Y
BBC-12-063 16APR2007      84 DAY     23JAN2007 16APR2007 Y      Y
BBC-13-025 03JAN2007      72 DAY     24OCT2006 03JAN2007 Y      Y

BBC-13-026 24JAN2007      84 DAY     02NOV2006 24JAN2007 Y      Y

Time                                                                                            Page 3 of 36
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                                                ADSL Dataset

USUBJID    SAFFL SAFEXC1 SAFEXC2                                                    MITTFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 N             Subject did not take at least one dose of study medication N

BBC-10-042 Y                                                                        Y
BBC-10-043 Y                                                                        Y
BBC-10-145 Y                                                                        Y

BBC-10-146 Y                                                                        Y
BBC-10-147 Y                                                                        Y
BBC-10-148 Y                                                                        Y
BBC-10-149 Y                                                                        Y
BBC-10-150 Y                                                                        Y
BBC-10-151 Y                                                                        Y
BBC-10-152 Y                                                                        Y
BBC-11-048 Y                                                                        Y
BBC-11-093 Y                                                                        Y
BBC-11-094 Y                                                                        Y
BBC-11-095 Y                                                                        Y
BBC-11-096 Y                                                                        Y

BBC-11-097 Y                                                                        Y

BBC-11-098 Y                                                                        Y
BBC-11-099 Y                                                                        Y
BBC-11-100 Y                                                                        Y

BBC-12-057 Y                                                                        N

BBC-12-058 Y                                                                        Y
BBC-12-059 Y                                                                        Y

BBC-12-060 Y                                                                        Y
BBC-12-061 Y                                                                        Y

BBC-12-062 Y                                                                        Y
BBC-12-063 Y                                                                        Y
BBC-13-025 Y                                                                        Y

BBC-13-026 Y                                                                        Y

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                                                ADSL Dataset

USUBJID    MITTEXC1
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 Subject is not included in the Safety Population

BBC-10-042
BBC-10-043
BBC-10-145

BBC-10-146
BBC-10-147
BBC-10-148
BBC-10-149
BBC-10-150
BBC-10-151
BBC-10-152
BBC-11-048
BBC-11-093
BBC-11-094
BBC-11-095
BBC-11-096

BBC-11-097

BBC-11-098
BBC-11-099
BBC-11-100

BBC-12-057

BBC-12-058
BBC-12-059

BBC-12-060
BBC-12-061

BBC-12-062
BBC-12-063
BBC-13-025

BBC-13-026

Time                                                                                            Page 5 of 36
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                                                ADSL Dataset

USUBJID    MITTEXC2                                                     PPROTFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041                                                              N

BBC-10-042                                                              Y
BBC-10-043                                                              Y
BBC-10-145                                                              N

BBC-10-146                                                              Y
BBC-10-147                                                              Y
BBC-10-148                                                              Y
BBC-10-149                                                              Y
BBC-10-150                                                              Y
BBC-10-151                                                              Y
BBC-10-152                                                              Y
BBC-11-048                                                              Y
BBC-11-093                                                              Y
BBC-11-094                                                              Y
BBC-11-095                                                              Y
BBC-11-096                                                              N

BBC-11-097                                                              N

BBC-11-098                                                              Y
BBC-11-099                                                              Y
BBC-11-100                                                              N

BBC-12-057 Subject did not have at least one post-baseline assessment   N
           of the primary endpoint
BBC-12-058                                                              Y
BBC-12-059                                                              N

BBC-12-060                                                              Y
BBC-12-061                                                              N

BBC-12-062                                                              Y
BBC-12-063                                                              Y
BBC-13-025                                                              N

BBC-13-026                                                              Y

Time                                                                                            Page 6 of 36
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                                                ADSL Dataset

USUBJID    PPROTEX1
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 Subject is not included in the MITT Population

BBC-10-042
BBC-10-043
BBC-10-145

BBC-10-146
BBC-10-147
BBC-10-148
BBC-10-149
BBC-10-150
BBC-10-151
BBC-10-152
BBC-11-048
BBC-11-093
BBC-11-094
BBC-11-095
BBC-11-096

BBC-11-097

BBC-11-098
BBC-11-099
BBC-11-100

BBC-12-057 Subject is not included in the MITT Population

BBC-12-058
BBC-12-059

BBC-12-060
BBC-12-061

BBC-12-062
BBC-12-063
BBC-13-025

BBC-13-026

Time                                                                                            Page 7 of 36
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                                                ADSL Dataset

USUBJID    PPROTEX2
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 Subject did not have a complete efficacy assessment at Week
           12
BBC-10-042
BBC-10-043
BBC-10-145 Subject did not have a complete efficacy assessment at Week
           12
BBC-10-146
BBC-10-147
BBC-10-148
BBC-10-149
BBC-10-150
BBC-10-151
BBC-10-152
BBC-11-048
BBC-11-093
BBC-11-094
BBC-11-095
BBC-11-096

BBC-11-097

BBC-11-098
BBC-11-099
BBC-11-100

BBC-12-057 Subject did not have a complete efficacy assessment at Week
           12
BBC-12-058
BBC-12-059 Subject did not have a complete efficacy assessment at Week
           12
BBC-12-060
BBC-12-061

BBC-12-062
BBC-12-063
BBC-13-025

BBC-13-026

Time                                                                                            Page 8 of 36
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                                                ADSL Dataset

USUBJID    PPROTEX3
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041

BBC-10-042
BBC-10-043
BBC-10-145

BBC-10-146
BBC-10-147
BBC-10-148
BBC-10-149
BBC-10-150
BBC-10-151
BBC-10-152
BBC-11-048
BBC-11-093
BBC-11-094
BBC-11-095
BBC-11-096

BBC-11-097

BBC-11-098
BBC-11-099
BBC-11-100

BBC-12-057

BBC-12-058
BBC-12-059

BBC-12-060
BBC-12-061 Subject did not receive at least 85% of prescribed doses of
           study medication
BBC-12-062
BBC-12-063
BBC-13-025 Subject did not receive at least 85% of prescribed doses of
           study medication
BBC-13-026

Time                                                                                            Page 9 of 36
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                                                ADSL Dataset

USUBJID    PPROTEX4                                                     COMPLFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041                                                              N

BBC-10-042                                                              Y
BBC-10-043                                                              Y
BBC-10-145                                                              N

BBC-10-146                                                              Y
BBC-10-147                                                              Y
BBC-10-148                                                              Y
BBC-10-149                                                              Y
BBC-10-150                                                              Y
BBC-10-151                                                              Y
BBC-10-152                                                              Y
BBC-11-048                                                              Y
BBC-11-093                                                              Y
BBC-11-094                                                              Y
BBC-11-095                                                              Y
BBC-11-096 Subject completed all visits but with major protocol         Y
           violations
BBC-11-097 Subject completed all visits but with major protocol         Y
           violations
BBC-11-098                                                              Y
BBC-11-099                                                              Y
BBC-11-100 Subject completed all visits but with major protocol         Y
           violations
BBC-12-057                                                              N

BBC-12-058                                                              Y
BBC-12-059                                                              N

BBC-12-060                                                              Y
BBC-12-061                                                              Y

BBC-12-062                                                              Y
BBC-12-063                                                              Y
BBC-13-025                                                              Y

BBC-13-026                                                              Y

Time                                                                                           Page 10 of 36
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                                                ADSL Dataset

USUBJID    STDYDISP                                                     STDYREAS              INCNDT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 Early Termination                                            Withdrawal By Subject 20DEC2006

BBC-10-042 Subject Completed All Visits And Protocol Requirements                             18DEC2006
BBC-10-043 Subject Completed All Visits And Protocol Requirements                             18DEC2006
BBC-10-145 Early Termination                                            Other                 01DEC2006

BBC-10-146 Subject Completed All Visits And Protocol Requirements                             29NOV2006
BBC-10-147 Subject Completed All Visits And Protocol Requirements                             01DEC2006
BBC-10-148 Subject Completed All Visits And Protocol Requirements                             30NOV2006
BBC-10-149 Subject Completed All Visits And Protocol Requirements                             30NOV2006
BBC-10-150 Subject Completed All Visits And Protocol Requirements                             29NOV2006
BBC-10-151 Subject Completed All Visits And Protocol Requirements                             08DEC2006
BBC-10-152 Subject Completed All Visits And Protocol Requirements                             15DEC2006
BBC-11-048 Subject Completed All Visits And Protocol Requirements                             28DEC2006
BBC-11-093 Subject Completed All Visits And Protocol Requirements                             02NOV2006
BBC-11-094 Subject Completed All Visits And Protocol Requirements                             06NOV2006
BBC-11-095 Subject Completed All Visits And Protocol Requirements                             07NOV2006
BBC-11-096 Subject Completed All Visits But With Major Protocol                               15NOV2006
           Violations
BBC-11-097 Subject Completed All Visits But With Major Protocol                               08NOV2006
           Violations
BBC-11-098 Subject Completed All Visits And Protocol Requirements                             27NOV2006
BBC-11-099 Subject Completed All Visits And Protocol Requirements                             17NOV2006
BBC-11-100 Subject Completed All Visits But With Major Protocol                               18DEC2006
           Violations
BBC-12-057 Early Termination                                            Other                 19OCT2006

BBC-12-058 Subject Completed All Visits And Protocol Requirements                             20OCT2006
BBC-12-059 Early Termination                                            Withdrawal By Subject 03NOV2006

BBC-12-060 Subject Completed All Visits And Protocol Requirements                             20OCT2006
BBC-12-061 Subject Completed All Visits And Protocol Requirements                             13DEC2006

BBC-12-062 Subject Completed All Visits And Protocol Requirements                             28DEC2006
BBC-12-063 Subject Completed All Visits And Protocol Requirements                             28DEC2006
BBC-13-025 Subject Completed All Visits And Protocol Requirements                             17OCT2006

BBC-13-026 Subject Completed All Visits And Protocol Requirements                             25OCT2006

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                                                ADSL Dataset

USUBJID    RANDDT    DTHDT DTHFL MISSDOSE TP1TRTR TP2TRTR TP3TRTR PSORTRTR FUPVISIT AEREPORT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-10-041 20DEC2006       N                                      N        N        N

BBC-10-042 10JAN2007       N            0 N       N       N       N        Y        Y
BBC-10-043 09FEB2007       N            0 N       N       N       N        Y        Y
BBC-10-145 08DEC2006       N            0 N       N       N       N        N        Y

BBC-10-146 11DEC2006       N            2 N       N       N       N        Y        N
BBC-10-147 12DEC2006       N            0 N       N       N       N        Y        N
BBC-10-148 12DEC2006       N            7 N       N       N       N        Y        Y
BBC-10-149 13DEC2006       N            0 N       N       N       N        Y        N
BBC-10-150 14DEC2006       N           11 N       N       N       N        Y        N
BBC-10-151 28DEC2006       N            0 N       N       N       N        Y        N
BBC-10-152 08JAN2007       N            0 N       N       N       N        Y        N
BBC-11-048 18JAN2007       N            1 N       N       N       N        Y        N
BBC-11-093 08NOV2006       N            0 N       N       N       N        Y        N
BBC-11-094 08NOV2006       N            6 N       N       N       N        Y        Y
BBC-11-095 10NOV2006       N            0 N       N       N       N        Y        Y
BBC-11-096 27NOV2006       N            4 N       N       N       N        Y        Y

BBC-11-097 28NOV2006       N            0 N       N       N       N        Y        Y

BBC-11-098 04DEC2006       N            0 N       N       N       N        Y        Y
BBC-11-099 08DEC2006       N            0 N       N       N       N        Y        N
BBC-11-100 11JAN2007       N            8 N       N       N       N        Y        N

BBC-12-057 14NOV2006       N            0                         N        N        N

BBC-12-058 15NOV2006       N            2 N       N       N       N        Y        Y
BBC-12-059 17NOV2006       N            3                         N        N        Y

BBC-12-060 06DEC2006       N            0 Y       Y       Y       Y        Y        Y
BBC-12-061 04JAN2007       N           13 N       N       N       N        Y        Y

BBC-12-062 15JAN2007       N            0 N       N       N       N        Y        N
BBC-12-063 23JAN2007       N            0 N       N       N       N        Y        Y
BBC-13-025 24OCT2006       N           15 N       N       N       N        Y        Y

BBC-13-026 02NOV2006       N            2 N       N       N       N        Y        Y

Time                                                                                           Page 12 of 36
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                                                ADSL Dataset

USUBJID    STUDYID SUBJID SITEID AGE AGEU  AGEGR1      SEX RACE                      RACEN
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 BBC     027        13  19 YEARS 18-29 years F   WHITE                         5

BBC-13-028 BBC     028        13  47 YEARS 40-49 years M   WHITE                         5
BBC-13-029 BBC     029        13  49 YEARS 40-49 years F   BLACK OR AFRICAN AMERICAN     4
BBC-13-030 BBC     030        13  63 YEARS 50-65 years M   WHITE                         5
BBC-13-031 BBC     031        13  37 YEARS 30-39 years F   WHITE                         5
BBC-13-032 BBC     032        13  47 YEARS 40-49 years M   BLACK OR AFRICAN AMERICAN     4

BBC-13-141 BBC     141        13  64 YEARS 50-65 years F   WHITE                         5

BBC-13-142 BBC     142        13  55 YEARS 50-65 years M   WHITE                         5
BBC-13-143 BBC     143        13  33 YEARS 30-39 years M   WHITE                         5
BBC-14-081 BBC     081        14  62 YEARS 50-65 years F   WHITE                         5
BBC-14-082 BBC     082        14  66 YEARS >65 years   M   WHITE                         5
BBC-14-083 BBC     083        14  39 YEARS 30-39 years F   WHITE                         5

BBC-14-084 BBC     084        14  72 YEARS >65 years   M   WHITE                         5
BBC-14-085 BBC     085        14  56 YEARS 50-65 years M   WHITE                         5
BBC-14-086 BBC     086        14  49 YEARS 40-49 years M   WHITE                         5
BBC-14-087 BBC     087        14  54 YEARS 50-65 years F   WHITE                         5
BBC-14-088 BBC     088        14  56 YEARS 50-65 years F   BLACK OR AFRICAN AMERICAN     4
BBC-14-117 BBC     117        14  44 YEARS 40-49 years F   BLACK OR AFRICAN AMERICAN     4
BBC-14-118 BBC     118        14  34 YEARS 30-39 years M   WHITE                         5
BBC-14-119 BBC     119        14  48 YEARS 40-49 years M   WHITE                         5

BBC-14-120 BBC     120        14  70 YEARS >65 years   M   WHITE                         5
BBC-14-121 BBC     121        14  55 YEARS 50-65 years M   WHITE                         5
BBC-14-122 BBC     122        14  34 YEARS 30-39 years M   WHITE                         5

BBC-14-123 BBC     123        14  52 YEARS 50-65 years F   ASIAN                         2
BBC-14-124 BBC     124        14  55 YEARS 50-65 years M   WHITE                         5
BBC-15-153 BBC     153        15  65 YEARS 50-65 years F   WHITE                         5

BBC-15-154 BBC     154        15  70 YEARS >65 years   F   WHITE                         5

BBC-15-155 BBC     155        15  56 YEARS 50-65 years F   WHITE                         5
BBC-15-156 BBC     156        15  35 YEARS 30-39 years F   WHITE                         5


Time                                                                                           Page 13 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    ETHNIC                 ETHNICN COUNTRY ARM   ACTARM TRT01P TRT01PN TRT01A TRT01AN TRTSDT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 HISPANIC OR LATINO           1         ARM C        ARM C        3 ARM C        3 02NOV2006

BBC-13-028 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 07NOV2006
BBC-13-029 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 15NOV2006
BBC-13-030 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 16NOV2006
BBC-13-031 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 21NOV2006
BBC-13-032 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 21NOV2006

BBC-13-141 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 21NOV2006

BBC-13-142 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 14DEC2006
BBC-13-143 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 19DEC2006
BBC-14-081 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 07NOV2006
BBC-14-082 HISPANIC OR LATINO           1         ARM D        ARM D        4 ARM D        4 13NOV2006
BBC-14-083 HISPANIC OR LATINO           1         ARM C        ARM C        3 ARM C        3 14NOV2006

BBC-14-084 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 14NOV2006
BBC-14-085 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 15NOV2006
BBC-14-086 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 15NOV2006
BBC-14-087 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 16NOV2006
BBC-14-088 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 20NOV2006
BBC-14-117 HISPANIC OR LATINO           1         ARM A        ARM A        1 ARM A        1 20NOV2006
BBC-14-118 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 28NOV2006
BBC-14-119 HISPANIC OR LATINO           1         ARM C        ARM C        3 ARM C        3 28NOV2006

BBC-14-120 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 28NOV2006
BBC-14-121 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 29NOV2006
BBC-14-122 HISPANIC OR LATINO           1         ARM D        ARM D        4 ARM D        4

BBC-14-123 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 19DEC2006
BBC-14-124 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 28DEC2006
BBC-15-153 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 04JAN2007

BBC-15-154 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 10JAN2007

BBC-15-155 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 11JAN2007
BBC-15-156 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 11JAN2007


Time                                                                                           Page 14 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    TRTEDT    TRTDURN TRTDURU TR01SDT   TR01EDT   INCNFL RANDFL RANDEXC1 RANDEXC2 RANDEXC3 RANDEXC4
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 24JAN2007      84 DAY     02NOV2006 24JAN2007 Y      Y

BBC-13-028 29JAN2007      84 DAY     07NOV2006 29JAN2007 Y      Y
BBC-13-029 13FEB2007      91 DAY     15NOV2006 13FEB2007 Y      Y
BBC-13-030 07FEB2007      84 DAY     16NOV2006 07FEB2007 Y      Y
BBC-13-031 12FEB2007      84 DAY     21NOV2006 12FEB2007 Y      Y
BBC-13-032 18DEC2006      28 DAY     21NOV2006 18DEC2006 Y      Y

BBC-13-141 24NOV2006       4 DAY     21NOV2006 24NOV2006 Y      Y

BBC-13-142 07MAR2007      84 DAY     14DEC2006 07MAR2007 Y      Y
BBC-13-143 13MAR2007      85 DAY     19DEC2006 13MAR2007 Y      Y
BBC-14-081 29JAN2007      84 DAY     07NOV2006 29JAN2007 Y      Y
BBC-14-082 06FEB2007      86 DAY     13NOV2006 06FEB2007 Y      Y
BBC-14-083 14FEB2007      93 DAY     14NOV2006 14FEB2007 Y      Y

BBC-14-084 06FEB2007      85 DAY     14NOV2006 06FEB2007 Y      Y
BBC-14-085 06FEB2007      84 DAY     15NOV2006 06FEB2007 Y      Y
BBC-14-086 06FEB2007      84 DAY     15NOV2006 06FEB2007 Y      Y
BBC-14-087 07FEB2007      84 DAY     16NOV2006 07FEB2007 Y      Y
BBC-14-088 12FEB2007      85 DAY     20NOV2006 12FEB2007 Y      Y
BBC-14-117 14FEB2007      87 DAY     20NOV2006 14FEB2007 Y      Y
BBC-14-118 20FEB2007      85 DAY     28NOV2006 20FEB2007 Y      Y
BBC-14-119 08JAN2007      42 DAY     28NOV2006 08JAN2007 Y      Y

BBC-14-120 20FEB2007      85 DAY     28NOV2006 20FEB2007 Y      Y
BBC-14-121 22FEB2007      86 DAY     29NOV2006 22FEB2007 Y      Y
BBC-14-122                                               Y      Y

BBC-14-123 12MAR2007      84 DAY     19DEC2006 12MAR2007 Y      Y
BBC-14-124 21MAR2007      84 DAY     28DEC2006 21MAR2007 Y      Y
BBC-15-153 17FEB2007      45 DAY     04JAN2007 17FEB2007 Y      Y

BBC-15-154 12FEB2007      34 DAY     10JAN2007 12FEB2007 Y      Y

BBC-15-155 05APR2007      85 DAY     11JAN2007 05APR2007 Y      Y
BBC-15-156 05APR2007      85 DAY     11JAN2007 05APR2007 Y      Y


Time                                                                                           Page 15 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    SAFFL SAFEXC1 SAFEXC2                                                    MITTFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 Y                                                                        Y

BBC-13-028 Y                                                                        Y
BBC-13-029 Y                                                                        Y
BBC-13-030 Y                                                                        Y
BBC-13-031 Y                                                                        Y
BBC-13-032 Y                                                                        Y

BBC-13-141 Y                                                                        N

BBC-13-142 Y                                                                        Y
BBC-13-143 Y                                                                        Y
BBC-14-081 Y                                                                        Y
BBC-14-082 Y                                                                        Y
BBC-14-083 Y                                                                        Y

BBC-14-084 Y                                                                        Y
BBC-14-085 Y                                                                        Y
BBC-14-086 Y                                                                        Y
BBC-14-087 Y                                                                        Y
BBC-14-088 Y                                                                        Y
BBC-14-117 Y                                                                        Y
BBC-14-118 Y                                                                        Y
BBC-14-119 Y                                                                        Y

BBC-14-120 Y                                                                        Y
BBC-14-121 Y                                                                        Y
BBC-14-122 N             Subject did not take at least one dose of study medication N

BBC-14-123 Y                                                                        Y
BBC-14-124 Y                                                                        Y
BBC-15-153 Y                                                                        Y

BBC-15-154 Y                                                                        Y

BBC-15-155 Y                                                                        Y
BBC-15-156 Y                                                                        Y


Time                                                                                           Page 16 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    MITTEXC1
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027

BBC-13-028
BBC-13-029
BBC-13-030
BBC-13-031
BBC-13-032

BBC-13-141

BBC-13-142
BBC-13-143
BBC-14-081
BBC-14-082
BBC-14-083

BBC-14-084
BBC-14-085
BBC-14-086
BBC-14-087
BBC-14-088
BBC-14-117
BBC-14-118
BBC-14-119

BBC-14-120
BBC-14-121
BBC-14-122 Subject is not included in the Safety Population

BBC-14-123
BBC-14-124
BBC-15-153

BBC-15-154

BBC-15-155
BBC-15-156


Time                                                                                           Page 17 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    MITTEXC2                                                     PPROTFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027                                                              N

BBC-13-028                                                              Y
BBC-13-029                                                              Y
BBC-13-030                                                              Y
BBC-13-031                                                              Y
BBC-13-032                                                              N

BBC-13-141 Subject did not have at least one post-baseline assessment   N
           of the primary endpoint
BBC-13-142                                                              Y
BBC-13-143                                                              Y
BBC-14-081                                                              Y
BBC-14-082                                                              Y
BBC-14-083                                                              N

BBC-14-084                                                              Y
BBC-14-085                                                              Y
BBC-14-086                                                              Y
BBC-14-087                                                              Y
BBC-14-088                                                              Y
BBC-14-117                                                              Y
BBC-14-118                                                              Y
BBC-14-119                                                              N

BBC-14-120                                                              Y
BBC-14-121                                                              Y
BBC-14-122                                                              N

BBC-14-123                                                              Y
BBC-14-124                                                              Y
BBC-15-153                                                              N

BBC-15-154                                                              N

BBC-15-155                                                              Y
BBC-15-156                                                              N


Time                                                                                           Page 18 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    PPROTEX1
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027

BBC-13-028
BBC-13-029
BBC-13-030
BBC-13-031
BBC-13-032

BBC-13-141 Subject is not included in the MITT Population

BBC-13-142
BBC-13-143
BBC-14-081
BBC-14-082
BBC-14-083

BBC-14-084
BBC-14-085
BBC-14-086
BBC-14-087
BBC-14-088
BBC-14-117
BBC-14-118
BBC-14-119

BBC-14-120
BBC-14-121
BBC-14-122 Subject is not included in the MITT Population

BBC-14-123
BBC-14-124
BBC-15-153

BBC-15-154

BBC-15-155
BBC-15-156


Time                                                                                           Page 19 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    PPROTEX2
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027

BBC-13-028
BBC-13-029
BBC-13-030
BBC-13-031
BBC-13-032 Subject did not have a complete efficacy assessment at Week
           12
BBC-13-141 Subject did not have a complete efficacy assessment at Week
           12
BBC-13-142
BBC-13-143
BBC-14-081
BBC-14-082
BBC-14-083 Subject did not have a complete efficacy assessment at Week
           12
BBC-14-084
BBC-14-085
BBC-14-086
BBC-14-087
BBC-14-088
BBC-14-117
BBC-14-118
BBC-14-119 Subject did not have a complete efficacy assessment at Week
           12
BBC-14-120
BBC-14-121
BBC-14-122 Subject did not have a complete efficacy assessment at Week
           12
BBC-14-123
BBC-14-124
BBC-15-153 Subject did not have a complete efficacy assessment at Week
           12
BBC-15-154 Subject did not have a complete efficacy assessment at Week
           12
BBC-15-155
BBC-15-156


Time                                                                                           Page 20 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    PPROTEX3
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 Subject did not receive at least 85% of prescribed doses of
           study medication
BBC-13-028
BBC-13-029
BBC-13-030
BBC-13-031
BBC-13-032

BBC-13-141

BBC-13-142
BBC-13-143
BBC-14-081
BBC-14-082
BBC-14-083

BBC-14-084
BBC-14-085
BBC-14-086
BBC-14-087
BBC-14-088
BBC-14-117
BBC-14-118
BBC-14-119

BBC-14-120
BBC-14-121
BBC-14-122

BBC-14-123
BBC-14-124
BBC-15-153

BBC-15-154

BBC-15-155
BBC-15-156 Subject did not receive at least 85% of prescribed doses of
           study medication

Time                                                                                           Page 21 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    PPROTEX4                                                     COMPLFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027                                                              Y

BBC-13-028                                                              Y
BBC-13-029                                                              Y
BBC-13-030                                                              Y
BBC-13-031                                                              Y
BBC-13-032                                                              N

BBC-13-141                                                              N

BBC-13-142                                                              Y
BBC-13-143                                                              Y
BBC-14-081                                                              Y
BBC-14-082                                                              Y
BBC-14-083                                                              N

BBC-14-084                                                              Y
BBC-14-085                                                              Y
BBC-14-086                                                              Y
BBC-14-087                                                              Y
BBC-14-088                                                              Y
BBC-14-117                                                              Y
BBC-14-118                                                              Y
BBC-14-119                                                              N

BBC-14-120                                                              Y
BBC-14-121                                                              Y
BBC-14-122                                                              N

BBC-14-123                                                              Y
BBC-14-124                                                              Y
BBC-15-153                                                              N

BBC-15-154                                                              N

BBC-15-155                                                              Y
BBC-15-156                                                              Y


Time                                                                                           Page 22 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    STDYDISP                                                     STDYREAS              INCNDT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 Subject Completed All Visits And Protocol Requirements                             26OCT2006

BBC-13-028 Subject Completed All Visits And Protocol Requirements                             30OCT2006
BBC-13-029 Subject Completed All Visits And Protocol Requirements                             07NOV2006
BBC-13-030 Subject Completed All Visits And Protocol Requirements                             08NOV2006
BBC-13-031 Subject Completed All Visits And Protocol Requirements                             14NOV2006
BBC-13-032 Early Termination                                            Other                 14NOV2006

BBC-13-141 Early Termination                                            Adverse Event         15NOV2006

BBC-13-142 Subject Completed All Visits And Protocol Requirements                             06DEC2006
BBC-13-143 Subject Completed All Visits And Protocol Requirements                             11DEC2006
BBC-14-081 Subject Completed All Visits And Protocol Requirements                             01NOV2006
BBC-14-082 Subject Completed All Visits And Protocol Requirements                             30OCT2006
BBC-14-083 Early Termination                                            Withdrawal By Subject 31OCT2006

BBC-14-084 Subject Completed All Visits And Protocol Requirements                             31OCT2006
BBC-14-085 Subject Completed All Visits And Protocol Requirements                             31OCT2006
BBC-14-086 Subject Completed All Visits And Protocol Requirements                             06NOV2006
BBC-14-087 Subject Completed All Visits And Protocol Requirements                             01NOV2006
BBC-14-088 Subject Completed All Visits And Protocol Requirements                             30OCT2006
BBC-14-117 Subject Completed All Visits And Protocol Requirements                             15NOV2006
BBC-14-118 Subject Completed All Visits And Protocol Requirements                             13NOV2006
BBC-14-119 Early Termination                                            Other                 31OCT2006

BBC-14-120 Subject Completed All Visits And Protocol Requirements                             30OCT2006
BBC-14-121 Subject Completed All Visits And Protocol Requirements                             30OCT2006
BBC-14-122 Early Termination                                            Other                 11DEC2006

BBC-14-123 Subject Completed All Visits And Protocol Requirements                             21NOV2006
BBC-14-124 Subject Completed All Visits And Protocol Requirements                             19DEC2006
BBC-15-153 Early Termination                                            Other                 21DEC2006

BBC-15-154 Early Termination                                            Other                 29DEC2006

BBC-15-155 Subject Completed All Visits And Protocol Requirements                             28DEC2006
BBC-15-156 Subject Completed All Visits And Protocol Requirements                             28DEC2006


Time                                                                                           Page 23 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    RANDDT    DTHDT DTHFL MISSDOSE TP1TRTR TP2TRTR TP3TRTR PSORTRTR FUPVISIT AEREPORT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-13-027 02NOV2006       N           16 Y       Y       Y       Y        Y        Y

BBC-13-028 07NOV2006       N            5 N       N       N       N        Y        Y
BBC-13-029 15NOV2006       N            0 N       N       N       N        Y        N
BBC-13-030 16NOV2006       N            0 N       N       N       N        Y        N
BBC-13-031 21NOV2006       N            0 N       N       N       N        Y        Y
BBC-13-032 21NOV2006       N            0                         N        N        N

BBC-13-141 21NOV2006       N            0                         N        N        Y

BBC-13-142 14DEC2006       N            0 N       N       N       N        Y        N
BBC-13-143 19DEC2006       N            0 N       N       N       N        Y        Y
BBC-14-081 07NOV2006       N            0 N       N       N       N        Y        N
BBC-14-082 13NOV2006       N            0 N       N       N       N        Y        N
BBC-14-083 14NOV2006       N           12                         N        N        Y

BBC-14-084 14NOV2006       N            2 N       N       N       N        Y        Y
BBC-14-085 15NOV2006       N            0 N       N       N       N        Y        N
BBC-14-086 15NOV2006       N            0 N       N       N       N        Y        N
BBC-14-087 16NOV2006       N            3 N       N       N       N        Y        Y
BBC-14-088 20NOV2006       N            6 N       N       N       N        Y        Y
BBC-14-117 20NOV2006       N            0 N       N       N       N        Y        Y
BBC-14-118 28NOV2006       N            1 N       N       N       N        Y        N
BBC-14-119 28NOV2006       N            0                         N        N        N

BBC-14-120 28NOV2006       N            0 N       N       N       N        Y        N
BBC-14-121 29NOV2006       N            0 N       N       N       N        Y        N
BBC-14-122 18DEC2006       N                                      N        N        N

BBC-14-123 19DEC2006       N            0 N       N       N       N        Y        Y
BBC-14-124 28DEC2006       N            0 N       N       N       N        Y        Y
BBC-15-153 04JAN2007       N            1                         N        N        Y

BBC-15-154 10JAN2007       N            0 N       N       N       N        Y        N

BBC-15-155 11JAN2007       N            0 N       N       N       N        Y        Y
BBC-15-156 11JAN2007       N           13 N       N       N       N        Y        Y


Time                                                                                           Page 24 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    STUDYID SUBJID SITEID AGE AGEU  AGEGR1      SEX RACE                      RACEN
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045 BBC     045        16  68 YEARS >65 years   M   WHITE                         5
BBC-16-046 BBC     046        16  71 YEARS >65 years   F   WHITE                         5

BBC-16-047 BBC     047        16  74 YEARS >65 years   M   WHITE                         5

BBC-16-157 BBC     157        16  62 YEARS 50-65 years M   WHITE                         5
BBC-16-158 BBC     158        16  71 YEARS >65 years   M   WHITE                         5

BBC-16-159 BBC     159        16  58 YEARS 50-65 years F   WHITE                         5
BBC-16-160 BBC     160        16  44 YEARS 40-49 years M   WHITE                         5





























Time                                                                                           Page 25 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    ETHNIC                 ETHNICN COUNTRY ARM   ACTARM TRT01P TRT01PN TRT01A TRT01AN TRTSDT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 28DEC2006
BBC-16-046 NOT HISPANIC OR LATINO       2         ARM D        ARM D        4 ARM D        4 28DEC2006

BBC-16-047 NOT HISPANIC OR LATINO       2         ARM A        ARM A        1 ARM A        1 02JAN2007

BBC-16-157 HISPANIC OR LATINO           1         ARM A        ARM A        1 ARM A        1 14DEC2006
BBC-16-158 NOT HISPANIC OR LATINO       2         ARM B        ARM B        2 ARM B        2 19DEC2006

BBC-16-159 NOT HISPANIC OR LATINO       2         ARM C        ARM C        3 ARM C        3 21DEC2006
BBC-16-160 HISPANIC OR LATINO           1         ARM D        ARM D        4 ARM D        4 28DEC2006





























Time                                                                                           Page 26 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    TRTEDT    TRTDURN TRTDURU TR01SDT   TR01EDT   INCNFL RANDFL RANDEXC1 RANDEXC2 RANDEXC3 RANDEXC4
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045 21MAR2007      84 DAY     28DEC2006 21MAR2007 Y      Y
BBC-16-046 27JAN2007      31 DAY     28DEC2006 27JAN2007 Y      Y

BBC-16-047 31JAN2007      30 DAY     02JAN2007 31JAN2007 Y      Y

BBC-16-157 07MAR2007      84 DAY     14DEC2006 07MAR2007 Y      Y
BBC-16-158 20MAR2007      92 DAY     19DEC2006 20MAR2007 Y      Y

BBC-16-159 14MAR2007      84 DAY     21DEC2006 14MAR2007 Y      Y
BBC-16-160 19MAR2007      82 DAY     28DEC2006 19MAR2007 Y      Y





























Time                                                                                           Page 27 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    SAFFL SAFEXC1 SAFEXC2                                                    MITTFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045 Y                                                                        Y
BBC-16-046 Y                                                                        Y

BBC-16-047 Y                                                                        Y

BBC-16-157 Y                                                                        Y
BBC-16-158 Y                                                                        Y

BBC-16-159 Y                                                                        Y
BBC-16-160 Y                                                                        Y





























Time                                                                                           Page 28 of 36
                                                Listing 1.0
                                                ADSL Dataset

USUBJID    MITTEXC1
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045
BBC-16-046

BBC-16-047

BBC-16-157
BBC-16-158

BBC-16-159
BBC-16-160





























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                                                ADSL Dataset

USUBJID    MITTEXC2                                                     PPROTFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045                                                              Y
BBC-16-046                                                              N

BBC-16-047                                                              N

BBC-16-157                                                              Y
BBC-16-158                                                              N

BBC-16-159                                                              Y
BBC-16-160                                                              Y





























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                                                ADSL Dataset

USUBJID    PPROTEX1
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045
BBC-16-046

BBC-16-047

BBC-16-157
BBC-16-158

BBC-16-159
BBC-16-160





























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                                                ADSL Dataset

USUBJID    PPROTEX2
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045
BBC-16-046 Subject did not have a complete efficacy assessment at Week
           12
BBC-16-047 Subject did not have a complete efficacy assessment at Week
           12
BBC-16-157
BBC-16-158

BBC-16-159
BBC-16-160





























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                                                ADSL Dataset

USUBJID    PPROTEX3
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045
BBC-16-046

BBC-16-047

BBC-16-157
BBC-16-158

BBC-16-159
BBC-16-160





























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                                                ADSL Dataset

USUBJID    PPROTEX4                                                     COMPLFL
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045                                                              Y
BBC-16-046                                                              N

BBC-16-047                                                              N

BBC-16-157                                                              Y
BBC-16-158 Subject completed all visits but with major protocol         Y
           violations
BBC-16-159                                                              Y
BBC-16-160                                                              Y





























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                                                ADSL Dataset

USUBJID    STDYDISP                                                     STDYREAS              INCNDT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045 Subject Completed All Visits And Protocol Requirements                             19DEC2006
BBC-16-046 Early Termination                                            Withdrawal By Subject 21DEC2006

BBC-16-047 Early Termination                                            Withdrawal By Subject 19DEC2006

BBC-16-157 Subject Completed All Visits And Protocol Requirements                             07DEC2006
BBC-16-158 Subject Completed All Visits But With Major Protocol                               05DEC2006
           Violations
BBC-16-159 Subject Completed All Visits And Protocol Requirements                             14DEC2006
BBC-16-160 Subject Completed All Visits And Protocol Requirements                             19DEC2006





























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                                                ADSL Dataset

USUBJID    RANDDT    DTHDT DTHFL MISSDOSE TP1TRTR TP2TRTR TP3TRTR PSORTRTR FUPVISIT AEREPORT
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
BBC-16-045 28DEC2006       N            0 N       N       N       N        Y        N
BBC-16-046 28DEC2006       N            0                         N        N        Y

BBC-16-047 02JAN2007       N            0                         N        N        N

BBC-16-157 14DEC2006       N            0 N       N       Y       Y        Y        N
BBC-16-158 19DEC2006       N            0 N       N       N       N        Y        N

BBC-16-159 21DEC2006       N            0 N       N       N       N        Y        N
BBC-16-160 28DEC2006       N            0 N       N       N       N        Y        Y





























Time                                                                                           Page 36 of 36
