Results generated by SPRINTT will provide the necessary evidence to indisputably identify a segment of the elderly population at risk for adverse outcomes whose medical needs are presently unmet, partly due to the vagueness of the current definition of frailty. The identification of a definite biological basis underlying frailty (i.e. skeletal muscle decline) opens new venues for research and development of interventions specifically aimed at slowing or reversing the progression of the PF&S condition of interest (especially towards disabling conditions). Regulatory appraisal of the clinical trial results (data generated during the project) will foster the development of innovative medicines for the condition of PF&S, by providing a reference framework and shared methodologies.