Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says "go" and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time.

The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

Total of all reporting groups

The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.

N = Number of participants with at least one non-missing measurement at the time point.

BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.

N = Number of participants with at least one non-missing measurement at the time point.

N = Number of participants with at least one non-missing measurement at the time point.

Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says "go" and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time.

The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.

The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

N = Number of patient with at least one non-missing measurement at the time point.

Placebo administered orally twice daily.