A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions

Primary objective is to demonstrate the superiority of riferminogene pecaplasmid
(XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the
treated leg or of death from any cause, whichever comes first, in critical limb ischemia
(CLI) patients with skin lesions.

Secondary objectives are to evaluate:

- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major
amputation;

- The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;

- The safety of riferminogene pecaplasmid in the study population.