                                                           The SAS System                      Friday, June 10, 2022 05:33:00 PM   1

                                                        The Mixed Procedure

                                                         Model Information

                                       Data Set                     ANA.DAT
                                       Dependent Variable           FEV1
                                       Covariance Structure         Unstructured
                                       Subject Effect               USUBJID
                                       Estimation Method            ML
                                       Residual Variance Method     None
                                       Fixed Effects SE Method      Model-Based
                                       Degrees of Freedom Method    Satterthwaite


                                                      Class Level Information

                                        Class      Levels    Values

                                        RACE            3    Black or African American
                                                             White Asian
                                        AVISIT          4    VIS2 VIS3 VIS4 VIS1
                                        SEX             2    Female Male
                                        ARMCD           2    TRT PBO
                                                           The SAS System                      Friday, June 10, 2022 05:33:00 PM   2

                                                        The Mixed Procedure

                                                      Class Level Information

                                        Class      Levels    Values

                                        USUBJID       200    PT1 PT10 PT100 PT101 PT102
                                                             PT103 PT104 PT105 PT106 PT107
                                                             PT108 PT109 PT11 PT110 PT111
                                                             PT112 PT113 PT114 PT115 PT116
                                                             PT117 PT118 PT119 PT12 PT120
                                                             PT121 PT122 PT123 PT124 PT125
                                                             PT126 PT127 PT128 PT129 PT13
                                                             PT130 PT131 PT132 PT133 PT134
                                                             PT135 PT136 PT137 PT138 PT139
                                                             PT14 PT140 PT141 PT142 PT143
                                                             PT144 PT145 PT146 PT147 PT148
                                                             PT149 PT15 PT150 PT151 PT152
                                                             PT153 PT154 PT155 PT156 PT157
                                                             PT158 PT159 PT16 PT160 PT161
                                                             PT162 PT163 PT164 PT165 PT166
                                                             PT167 PT168 PT169 PT17 PT170
                                                             PT171 PT172 PT173 PT174 PT175
                                                             PT176 PT177 PT178 PT179 PT18
                                                             PT180 PT181 PT182 PT183 PT184
                                                             PT185 PT186 PT187 PT188 PT189
                                                             PT19 PT190 PT191 PT192 PT193
                                                             PT194 PT195 PT196 PT197 PT198
                                                             PT199 PT2 PT20 PT200 PT21 PT22
                                                             PT23 PT24 PT25 PT26 PT27 PT28
                                                             PT29 PT3 PT30 PT31 PT32 PT33
                                                             PT34 PT35 PT36 PT37 PT38 PT39
                                                             PT4 PT40 PT41 PT42 PT43 PT44
                                                             PT45 PT46 PT47 PT48 PT49 PT5
                                                             PT50 PT51 PT52 PT53 PT54 PT55
                                                             PT56 PT57 PT58 PT59 PT6 PT60
                                                             PT61 PT62 PT63 PT64 PT65 PT66
                                                             PT67 PT68 PT69 PT7 PT70 PT71
                                                             PT72 PT73 PT74 PT75 PT76 PT77
                                                             PT78 PT79 PT8 PT80 PT81 PT82
                                                             PT83 PT84 PT85 PT86 PT87 PT88
                                                             PT89 PT9 PT90 PT91 PT92 PT93
                                                             PT94 PT95 PT96 PT97 PT98 PT99


                                                            Dimensions

                                                Covariance Parameters            10
                                                Columns in X                     20
                                                Columns in Z                      0
                                                Subjects                        200
                                                Max Obs per Subject               4


                                                      Number of Observations

                                            Number of Observations Read             800
                                            Number of Observations Used             537
                                                           The SAS System                      Friday, June 10, 2022 05:33:00 PM   3

                                                        The Mixed Procedure

                                                      Number of Observations

                                            Number of Observations Not Used         263


                                                         Iteration History

                                    Iteration    Evaluations        -2 Log Like       Criterion

                                            0              1      3550.09248629
                                            1              2      3397.58232654      0.00000830
                                            2              1      3397.57220025      0.00000000


                                                     Convergence criteria met.


                                                         Estimated R Matrix
                                                           for USUBJID PT1

                                                     Row        Col1        Col2

                                                       1     25.9989      7.2159
                                                       2      7.2159     93.9227


                                                       Estimated R Correlation
                                                       Matrix for USUBJID PT1

                                                     Row        Col1        Col2

                                                       1      1.0000      0.1460
                                                       2      0.1460      1.0000


                                                  Covariance Parameter Estimates

                                 Cov Parm    Subject    Estimate     Alpha       Lower       Upper

                                 UN(1,1)     USUBJID     25.9989      0.05     20.8037     33.4272
                                 UN(2,1)     USUBJID      2.5419      0.05     -1.3222      6.4060
                                 UN(2,2)     USUBJID     14.4620      0.05     11.4881     18.7679
                                 UN(3,1)     USUBJID      7.2159      0.05     -1.7266     16.1583
                                 UN(3,2)     USUBJID      0.6609      0.05     -7.0819      8.4037
                                 UN(3,3)     USUBJID     93.9227      0.05     74.7945      121.50
                                 UN(4,1)     USUBJID     14.0451      0.05      7.8623     20.2279
                                 UN(4,2)     USUBJID      4.7227      0.05     -0.1663      9.6116
                                 UN(4,3)     USUBJID     12.9820      0.05     -1.3178     27.2818
                                 UN(4,4)     USUBJID     39.7740      0.05     31.8129     51.1652


                                                          Fit Statistics

                                               -2 Log Likelihood              3397.6
                                               AIC (Smaller is Better)        3439.6
                                               AICC (Smaller is Better)       3441.4
                                                           The SAS System                      Friday, June 10, 2022 05:33:00 PM   4

                                                        The Mixed Procedure

                                                          Fit Statistics

                                               BIC (Smaller is Better)        3508.8


                                                  Null Model Likelihood Ratio Test

                                                    DF    Chi-Square      Pr > ChiSq

                                                     9        152.52          <.0001


                                                    Solution for Fixed Effects

                                                                                         Standard
   Effect          RACE                         AVISIT    SEX       ARMCD    Estimate       Error      DF    t Value    Pr > |t|

   Intercept                                                                  30.7748      0.8767     222      35.10      <.0001
   ARMCD                                                            TRT        3.7751      1.0641     148       3.55      0.0005
   ARMCD                                                            PBO             0           .       .        .         .
   AVISIT                                       VIS2                           4.8376      0.7948     146       6.09      <.0001
   AVISIT                                       VIS3                          10.3459      0.8156     158      12.68      <.0001
   AVISIT                                       VIS4                          15.0480      1.3027     140      11.55      <.0001
   AVISIT                                       VIS1                                0           .       .        .         .
   AVISIT*ARMCD                                 VIS2                TRT      -0.03937      1.1195     141      -0.04      0.9720
   AVISIT*ARMCD                                 VIS2                PBO             0           .       .        .         .
   AVISIT*ARMCD                                 VIS3                TRT       -0.6923      1.1773     161      -0.59      0.5573
   AVISIT*ARMCD                                 VIS3                PBO             0           .       .        .         .
   AVISIT*ARMCD                                 VIS4                TRT        0.6250      1.8367     131       0.34      0.7342
   AVISIT*ARMCD                                 VIS4                PBO             0           .       .        .         .
   AVISIT*ARMCD                                 VIS1                TRT             0           .       .        .         .
   AVISIT*ARMCD                                 VIS1                PBO             0           .       .        .         .
   RACE            Black or African American                                   1.5361      0.6146     173       2.50      0.0134
   RACE            White                                                       5.6436      0.6548     161       8.62      <.0001
   RACE            Asian                                                            0           .       .        .         .
   SEX                                                    Female               0.3275      0.5235     171       0.63      0.5324
   SEX                                                    Male                      0           .       .        .         .


                                                   Type 3 Tests of Fixed Effects

                                           Num     Den
                          Effect            DF      DF    Chi-Square    F Value      Pr > ChiSq    Pr > F

                          ARMCD              1     171         32.49      32.49          <.0001    <.0001
                          AVISIT             3     150        433.50     144.50          <.0001    <.0001
                          AVISIT*ARMCD       3     150          0.79       0.26          0.8526    0.8525
                          RACE               2     170         76.24      38.12          <.0001    <.0001
                          SEX                1     171          0.39       0.39          0.5316    0.5324
