Figure 1: Schematic representation of study design. After a recruitment period of 12 months, eligible subjects were evaluated and initially treated with Longastatin 0.1 mg administered subcutaneously every 8 hours (i.e. three times daily, t.i.d.). At +14 days Longastatin LAR was begun, with an overlap of 14 days with Longastatin, which was discontinued at +28 days. Subjects had been followed up for 12 months under Longastatin LAR treatment. The original study, as registered by the local IRB, was extended to 24 months