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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
                   Wound infection                    0       0      1       1      1       1      0      0
                   Arthritis infective                0       0      0       0      0       0      1      1
                   Bronchopneumonia                   0       0      0       0      0       0      1      1
                   Clostridium difficile colitis      0       0      0       0      0       0      3      3
                   Cytomegalovirus viremia            0       0      0       0      0       0      1      1
                   Febrile cold (excl flu like illness)   0   0      0       0      0       0      1      1
                   Febrile infection                  0       0      0       0      0       0      1      1
                   GI infection                       0       0      0       0      0       0      1      1
                   Infection pseudomonas aeruginosa   0       0      0       0      0       0      1      1
                   MRSA colonization                  0       0      0       0      0       0      1      1
                   MRSA wound infection               0       0      0       0      0       0      1      1
                   Pneumonia aspergillus              0       0      0       0      0       0      1      1
                   Septic joint                       0       0      0       0      0       0      1      1
                   Suppurative peritonitis, other     0       0      0       0      0       0      1      1
                   Respiratory, thoracic and mediastinal   44   58   52     85      96     143    32      40
                   disorders                        (16.3%)        (18.6%)        (17.5%)        (9.2%)
                   Dyspnea                            16     23      19     24      35     47     10      10
                   Respiratory failure                6       6      11     11      17     17      2      2
                   COPD exacerbation                  4       4      11     20      15     24      5      5
                   Pleural effusion                   3       3      3       4      6       7      3      3
                   Shortness of breath                4       4      2       3      6       7      0      0
                   Aspiration pneumonia               2       2      1       1      3       3      1      1
                   Epistaxis                          0       0      3       3      3       3      2      2
                   Pulmonary hypertension             2       3      1       1      3       4      2      2
                   Respiratory distress               3       3      0       0      3       3      0      0
                   COPD                               1       1      1       1      2       2      0      0
                   Dyspnea exertional                 1       1      1       1      2       2      0      0
                   Hypoxemia                          0       0      2       2      2       2      0      0
                   Pneumonitis                        0       0      2       2      2       2      0      0
                   Pulmonary edema                    0       0      2       2      2       2      1      1
                   Pulmonary infiltration             0       0      2       2      2       2      1      1
                   Pulmonary thromboembolism          2       2      0       0      2       2      0      0
                   Acute respiratory failure          0       0      1       1      1       1      0      0
                   Apnea                              1       1      0       0      1       1      0      0
                   Asthma                             1       1      0       0      1       1      0      0
                   Asthma aggravated                  0       0      1       1      1       1      0      0
                   Bronchitis asthmatic               0       0      1       1      1       1      0      0
                   Difficulty breathing               0       0      1       1      1       1      0      0
                   Dyspnea exacerbated                1       1      0       0      1       1      0      0
                   Exacerbation of asthma             0       0      1       1      1       1      0      0
                   Hemoptysis                         0       0      1       1      1       1      1      3
                   Hypoxia                            0       0      1       1      1       1      3      3
                   Productive cough                   0       0      1       1      1       1      0      0
                   Pulmonary mass                     1       1      0       0      1       1      0      0
                   Respiratory arrest                 1       2      0       0      1       2      0      0
                   Chronic obstructive pulmonary disease   0   0     0       0      0       0      3      3
                   Cough                              0       0      0       0      0       0      1      1
                   Hypoventilation                    0       0      0       0      0       0      1      1
                   Pulmonary embolus                  0       0      0       0      0       0      1      1
                   Tachypnea                          0       0      0       0      0       0      1      1
                   General disorders and administration site   35   43   30   40    65     83     36      46
                   conditions                       (13.0%)        (10.7%)        (11.8%)       (10.4%)
                   Chest pain                         16     20      10     11      26     31     17      26
                   Weakness                           3       5      7       7      10     12      0      0

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