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    Figure 80.  Freedom from Death over the Full Randomized Period (Part 1).

                   Figure 81.  Freedom from HF Hospitalization or Death over the Full Randomized Period (Part 1).

                   Also performed were an Anderson-Gill Model with Frailty, Anderson Gill Model with Robust Sandwich Estimates (RSE) and Negative
                   Binomial Regression using an endpoint of time to HF hospitalization or death in Part 1 and Part 1 + Part 2. As seen in the gray rows
                   in the tables below, all the competing risk analyses taking death into account as a competing risk show that there was no evidence of
                   a treatment-by-gender interaction if a p-value of 0.05 is used. However, when analyses for interaction by gender are conducted, a p-
                   value of 0.15 is typically used because the analysis is typically not powered appropriately. When considering a p-value of 0.15, there
                   was some evidence of treatment-by-gender interaction in the competing risk analyses under the following models:
                      AG Model with Frailty for Part 1
                      NB Regression for Part 1
                      AG Model with Robust Sandwich Estimate for Part 1 + Part 2
                      GEE NB Regression for Part 1 + Part 2

                   Table 9.  Results of treatment by gender interaction using different statistical models

                   Models                                               Estimate   SE           p-value
                   Part 1
                   Cox Model: Endpoint of first HFR hospitalization or Death    -0.113   0.289   0.6968
                   Cox Model: Endpoint of first HFR hospitalization     -0.330     0.327        0.3131
                   AG Model with Frailty: Endpoint of HFR hospitalization or Death    -0.373   0.239   0.1211
                   AG Model with Frailty: Endpoint of HFR hospitalization    -0.531   0.262     0.0459
                   AG Model with RSE: Endpoint of HFR hospitalization or Death    -0.433   0.316   0.1712
                   AG Model with RSE: Endpoint of HFR hospitalization    -0.577    0.360        0.1094
                   NB Regression: Endpoint of HFR hospitalization or Death    -0.412   0.242    0.0896
                   NB Regression: Endpoint of HFR hospitalization       -0.573     0.191        0.0027
                   Part 1 + Part 2
                   Cox Model: Endpoint of first HFR hospitalization or Death    -0.204   0.249   0.4121*

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