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    Table 13.  Serious Adverse Events Over Part 1 and Part 2

                                                    Part 1                                      Part 2
                                                    Treatment      Control       All Patients   All Patients
                                                    (270)          (280)         (550)          (347)
                                                    Subjects  Events   Subjects  Events   Subjects   Events  Subjects  Events
                    International normalized ratio decreased   0   0   1     1       1      1      0      0
                    Mediastinoscopy                    1      1       0      0       1      1      0      0
                    Pulmonary arterial pressure increased   1   1     0      0       1      1      1      1
                    QT interval prolonged              1      1       0      0       1      1      0      0
                    Ventricular filling pressure increased   0   0    1      1       1      1      0      0
                    Blood sugar abnormal               0      0       0      0       0      0      1      1
                    INR decreased                      0      0       0      0       0      0      1      1
                    Urinary output diminished          0      0       0      0       0      0      1      1
                    Psychiatric disorders           7 (2.6%)   7   7 (2.5%)   7   14 (2.5%)   14   6 (1.7%)   7
                    Acute mental status changes        3      3       7      7      10     10      4      4
                    Agitation                          1      1       0      0       1      1      0      0
                    Delirium toxic                     1      1       0      0       1      1      0      0
                    Panic attack                       1      1       0      0       1      1      0      0
                    Suicidal ideation                  1      1       0      0       1      1      0      0
                    Mental status changes              0      0       0      0       0      0      2      2
                    Withdrawal syndrome                0      0       0      0       0      0      1      1
                    Hepatobiliary disorders         6 (2.2%)   8   7 (2.5%)   8   13 (2.4%)   16   2 (0.6%)   3
                    Acute cholecystitis                4      4       0      0       4      4      0      0
                    Cholecystitis                      1      1       3      3       4      4      0      0
                    Cholelithiasis                     2      2       0      0       2      2      2      2
                    Gallstones                         0      0       1      1       1      1      1      1
                    Hepatic fibrosis                   0      0       1      2       1      2      0      0
                    Injury to liver                    1      1       0      0       1      1      0      0
                    Liver disorder                     0      0       1      1       1      1      0      0
                    Portal hypertension                0      0       1      1       1      1      0      0
                    Neoplasms benign, malignant and   5 (1.9%)   7   4 (1.4%)   5   9 (1.6%)   12   5 (1.4%)   5
                    unspecified (incl cysts and polyps)
                    Lung cancer                        2      2       1      1       3      3      1      1
                    Large cell lung cancer             0      0       1      1       1      1      0      0
                    Lung nodule                        0      0       1      1       1      1      0      0
                    Lymphocytic leukemia               0      0       1      1       1      1      0      0
                    Myelodysplastic syndrome           1      1       0      0       1      1      0      0
                    Ovarian cancer                     1      1       0      0       1      1      0      0
                    Prostate cancer metastatic         0      0       1      1       1      1      0      0
                    Skin cancer                        1      1       0      0       1      1      0      0
                    Small cell carcinoma of the lung   1      2       0      0       1      2      0      0
                    Adenoma                            0      0       0      0       0      0      1      1
                    Breast cancer                      0      0       0      0       0      0      1      1
                    Esophageal cancer                  0      0       0      0       0      0      1      1
                    Lymphoma                           0      0       0      0       0      0      1      1
                    Endocrine disorders             2 (0.7%)   2   1 (0.4%)   1   3 (0.5%)   3   1 (0.3%)   1
                    Adrenal insufficiency              1      1       0      0       1      1      0      0
                    Hypothyroidism                     1      1       0      0       1      1      1      1
                    Myxedema                           0      0       1      1       1      1      0      0
                    Immune system disorders         2 (0.7%)   2   1 (0.4%)   1   3 (0.5%)   3   0 (0.0%)   0
                    Amyloidosis                        1      1       0      0       1      1      0      0
                    Heart transplant rejection         0      0       1      1       1      1      0      0
                    Transplant rejection               1      1       0      0       1      1      0      0
                    Skin and subcutaneous tissue disorders   0 (0.0%)   0   3 (1.1%)   3   3 (0.5%)   3   3 (0.9%)   4
                    Diabetic ulcer                     0      0       1      1       1      1      0      0
                    Foot ulcer                         0      0       1      1       1      1      0      0
                    Venous stasis ulcer                0      0       1      1       1      1      0      0
                    Decubitus ulcer                    0      0       0      0       0      0      1      1
                    Rash                               0      0       0      0       0      0      1      2

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