Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).


Options:
A: Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline (Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005)); Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30 (Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 30); Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66 (Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 66); NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline (Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201)); NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12 (Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 12); NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60 (Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 60); Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline (Baseline of B3461020 (Fx-005)); Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 30 (Baseline of B3461020 (Fx-005), Month 30); Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 66 (Baseline of B3461020 (Fx-005), Month 66); NonVal30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline (Baseline of B3461022 (Fx1A-201)); NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 12 (Baseline of B3461022 (Fx1A-201), Month 12); NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 60 (Baseline of B3461022 (Fx1A-201), Month 60); Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 30 (Month 30 (Baseline of B3461023)); Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 66 (Month 66 (Month 36 of B3461023)); NonVal30Met Group: Karnofsky Performance Scale (KPS) Score at Baseline (Baseline of B3461022 (Fx1A-201)); NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 12 (Baseline of B3461022 (Fx1A-201), Month 12); NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 60 (Baseline of B3461022 (Fx1A-201), Month 60); Val30Met Group: Number of Participants by Ambulation Stage at Baseline (Baseline of B3461020 (Fx-005)); Val30Met Group: Number of Participants by Ambulation Stage at Month 30 (Month 30); Val30Met Group: Number of Participants by Ambulation Stage at Month 66 (Month 66); NonVal30Met Group: Number of Participants by Ambulation Stage at Baseline (Baseline of B3461022 (Fx1A-201)); NonVal30Met Group: Number of Participants by Ambulation Stage at Month 12 (Month 12); NonVal30Met Group: Number of Participants by Ambulation Stage at Month 60 (Month 60)
B: Hierarchical Combination of All-Cause Mortality and Frequency of Cardiovascular-Related Hospitalizations (Baseline up to Month 30)
C: Modified Neuropathy Impairment Score +7 (mNIS+7) (18mo)
D: Change From Baseline In The Modified Neuropathy Impairment Score (mNIS) +7 Composite Score at Week 66 (Baseline and Week 66); Change From Baseline In The Norfolk Quality Of Life Diabetic Neuropathy (QoL-DN) Questionnaire at Week 66 (Baseline and Week 66)

Answer: D