Common use of STATISTICAL PROCEDURES Clause in Contracts

STATISTICAL PROCEDURES. The primary objective of this study is to evaluate data obtained following six months of standard-of-care osteoporosis treatment, including treatment with alendronate, in subjects who have previously received 18 months of blinded treatment with BA058 Injection 80 µg/Placebo. Safety data will be obtained with clinical, laboratory and radiologic assessment. Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of this study during which the subjects will continue to receive alendronate treatment for an additional 18 months. The specific objectives of this study are to: · Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide information on the vertebral fracture rate of subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide additional information on BMD change and osteoporosis status associated with 24 months of treatment with alendronate after 18 months of treatment with BA058 Injection 80 µg/Placebo. The analysis performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Additional analyses performed on data in this study will be descriptive in nature. Full details of the statistical procedures to be used will be provided in the Statistical Analysis Plan.

STATISTICAL PROCEDURES. The primary objective of this study is to evaluate data obtained following six months of standard-of-care osteoporosis treatment, including treatment with alendronate, in subjects who have previously received 18 months of blinded treatment with BA058 Injection 80 µgAbaloparatide-SC/Placebo. Safety data will be obtained with clinical, laboratory and radiologic assessment. Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of this study during which the subjects will continue to receive alendronate treatment for an additional 18 months. The specific objectives of this study are to: · Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µgAbaloparatide-SC/Placebo. · Provide information on the vertebral fracture rate of subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µgAbaloparatide-SC/Placebo. · Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µgAbaloparatide-SC/Placebo. · Provide additional information on BMD change and osteoporosis status associated with 24 months of treatment with alendronate after 18 months of treatment with BA058 Injection 80 µgAbaloparatide-SC/Placebo. The analysis performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Additional analyses Analyses will also be performed on data in this study will be descriptive in naturecumulatively at Month 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of the statistical procedures to be used will be provided in the Statistical Analysis Plan.