Figure 1.
Trial profile through 104 weeks. A total of five patients left the trial because they ‘no longer met study criteria.' For the three patients in the placebo group, (1) the patient had insulin regimen altered, which is against the protocol guidance, (2) the patient met discontinuation criteria for sustained elevated serum creatinine, and (3) the patient was inappropriately randomized with a high screening potassium and removed a few days after starting treatment. The patient in the 5-mg group had myasthenia gravis, was administered prednisone for treatment and was asked to be discontinued by the medical monitor. The patient in the 10-mg group was discontinued owing to serum creatinine greater than two times the baseline at day 78.