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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
                    Chronic renal failure worsened     0      0       1      1       1      1      0      0
                    End stage renal failure            0      0       1      1       1      1      0      0
                    Hematuria                          1      1       0      0       1      1      0      0
                    Kidney failure                     1      1       0      0       1      1      0      0
                    Lupus nephritis                    0      0       1      1       1      1      0      0
                    Nephrolithiasis                    1      1       0      0       1      1      0      0
                    Renal artery stenosis              1      1       0      0       1      1      0      0
                    Renal function abnormal            1      1       0      0       1      1      0      0
                    Uremia                             0      0       1      1       1      1      0      0
                    Urinary retention                  0      0       1      1       1      1      2      2
                    Chronic renal failure              0      0       0      0       0      0      1      1
                    Kidney disorder                    0      0       0      0       0      0      1      1
                    Renal disease                      0      0       0      0       0      0      1      1
                    Renal failure acute on chronic     0      0       0      0       0      0      1      1
                    Gastrointestinal disorders        24      35     31     49      55     84      36     53
                                                     (8.9%)        (11.1%)        (10.0%)        (10.4%)
                    GI bleed                           6      7       7      7      13     14      9      10
                    Abdominal pain                     3      3       5      6       8      9      2      2
                    Diarrhea                           4      4       1      1       5      5      2      2
                    Nausea                             4      4       1      1       5      5      0      0
                    Gastritis                          3      3       1      1       4      4      1      1
                    Gastrointestinal bleed             0      0       4      6       4      6      6      8
                    Vomiting                           2      2       2      4       4      6      1      1
                    Constipation                       0      0       3      3       3      3      1      1
                    Pancreatitis                       2      2       1      1       3      3      1      1
                    Ascites                            2      2       0      0       2      2      0      0
                    Dysphagia                          1      1       1      1       2      2      2      2
                    Emesis                             2      2       0      0       2      2      0      0
                    Esophagitis                        0      0       2      2       2      2      0      0
                    Gastroparesis                      0      0       2      2       2      2      1      2
                    Abdominal bloating                 1      1       0      0       1      1      0      0
                    Abdominal wall hematoma            0      0       1      1       1      1      0      0
                    Chronic epigastric pain            0      0       1      1       1      1      0      0
                    Dental caries                      0      0       1      1       1      1      0      0
                    Esophageal spasm                   1      1       0      0       1      1      0      0
                    Esophagitis ulcerative             1      1       0      0       1      1      0      0
                    Gastric polyps                     0      0       1      1       1      1      0      0
                    Gastritis erosive                  0      0       1      1       1      1      0      0
                    Ileus                              0      0       1      1       1      1      0      0
                    Incarcerated umbilical hernia      0      0       1      1       1      1      0      0
                    Ischemic colitis                   0      0       1      1       1      1      1      2
                    Melena                             1      1       0      0       1      1      0      0
                    Odynophagia                        0      0       1      1       1      1      0      0
                    Rectal bleeding                    0      0       1      3       1      3      1      1
                    Rectal fistula                     0      0       1      1       1      1      0      0
                    Rectal prolapse                    0      0       1      1       1      1      0      0
                    Ventral hernia                     1      1       0      0       1      1      2      4
                    Decay dental                       0      0       0      0       0      0      1      1
                    Duodenitis                         0      0       0      0       0      0      1      1
                    Fecal impaction (causing obstruction)   0   0     0      0       0      0      1      1
                    Gastric ulcer                      0      0       0      0       0      0      1      1
                    Gastric ulcer haemorrhage          0      0       0      0       0      0      1      1
                    Gastro intestinal bleed            0      0       0      0       0      0      1      1
                    Gastrointestinal bleeding          0      0       0      0       0      0      2      2

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