A negative percentage change from baseline at Month 6 indicates a reduction in serum TTR level.

Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at Month 6.

A negative percentage change from baseline indicates a reduction in serum TTR level.

Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.

The mNIS+7 is a composite score that measures neurologic impairment which includes the following components: physical exam of lower limbs, upper limbs and cranial nerves to assess motor strength/weakness, electrophysiologic measurement of small and large nerve fiber function, sensory testing and postural blood pressure. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.

Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.

The Norfolk QoL-DN questionnaire is a standardized 35-item patient-reported outcomes measure that is sensitive to the different features of diabetic neuropathy - small fiber, large fiber, and autonomic nerve function. The minimum and maximum values are -4 and 136, respectively. A higher score indicates a worse outcome.

Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.

PND Scores: Stage 0: No symptoms, Stage 1: Sensory disturbances but preserved walking capabilities, Stage 2: Impaired walking capacity, but ability to walk without a stick or crutches, Stage 3A/B: Walking with help of 1 or 2 sticks or crutches, Stage 4: confined to wheel chair. For each stage (0-4) at baseline, the number of participants is presented at their worst post-baseline score for each stage (0-4) post-baseline. Worst post-baseline is defined the highest PND classification for a participant recorded after the first dose of study drug.

Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected post-baseline. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.