Population | Number of patients | Comments |
---|---|---|
Intention-to-treat population | 8,010 | Eighteen randomly assigned patients withdrew consent to participate before starting treatment. |
   Two-arm randomization option | 1,828 |  |
   Four-arm randomization option | 6,182 |  |
Primary core analysis population | 8,010 | Follow-up for two sequential treatment groups is censored at 2 years (time of treatment switch). |
Monotherapy population | 4,922 | Patients who were randomly assigned to receive 5 years of tamoxifen alone or letrozole alone. |
   Two-arm randomization option | 1,828 |  |
   Four-arm randomization option | 3,094 |  |
Sequential treatment analysis population | 6,182 | Patients in the intention-to-treat population enrolled in the four-arm randomization option. |