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    Table 11.  Non-serious Adverse Device Events Over Part 1 and Part 2
                                                                Part 1                              Part 2
                                          TREATMENT (270)    CONTROL (280)   ALL PATIENTS (550)
                                         Subjects   Events   Subjects   Events   Subjects   Events   Subjects   Events
                   Hemoptysis               1        1        1        1        2        2        0       0
                   Dyspnea                  1        1        0        0        1        1        0       0
                   Cardiac disorders    1 (0.4%)   1 (16.7%)   1 (0.4%)   1 (9.1%)   2 (0.4%)   2 (11.8%)   0 (0%)   0 (0%)
                   Congestive heart failure   1      1        0        0        1        1        0       0
                   Ventricular tachycardia   0       0        1        1        1        1        0       0
                   Nervous system disorders   0 (0.0%)   0 (0.0%)   1 (0.4%)   1 (9.1%)   1 (0.2%)   1 (5.9%)   0 (0%)   0 (0%)
                   Dizziness                0        0        1        1        1        1        0       0
                   Vascular disorders   0 (0.0%)   0 (0.0%)   1 (0.4%)   1 (9.1%)   1 (0.2%)   1 (5.9%)   0 (0%)   0 (0%)
                   Vessel perforation       0        0        1        1        1        1        0       0

                   Non-Serious Adverse Events not related to the device

                   Table 12.  Non-Serious Adverse Events not related to the device Over Part 1 and Part 2

                                                            Part 1                                Part 2
                                       Treatment (270)      Control (280)   All Patients (550)   All Patients (347)
                                      Subjects   Events   Subjects   Events   Subjects   Events   Subjects   Events
                   All Patients with an   216 (80.0%)   1229   223   1135   439     2364     219       787
                   Event                                  (79.6%)          (79.8%)         (63.1%)
                   Blood and lymphatic   27 (10.0%)   37   22 (7.9%)   28   49 (8.9%)   65   13 (3.7%)   16
                   system disorders
                   Cardiac disorders   81 (30.0%)   140   69 (24.6%)   117   150     257   49 (14.1%)   71
                                                                           (27.3%)
                   Congenital, familial   0 (0.0%)   0   0 (0.0%)    0     0 (0.0%)   0    3 (0.9%)     3
                   and genetic disorders
                   Ear and labyrinth   6 (2.2%)    6     2 (0.7%)    2     8 (1.5%)   8    2 (0.6%)     2
                   disorders
                   Endocrine disorders   4 (1.5%)   4    9 (3.2%)   10    13 (2.4%)   14   7 (2.0%)     7
                   Eye disorders      12 (4.4%)    12    14 (5.0%)   16   26 (4.7%)   28   7 (2.0%)     8
                   Gastrointestinal   64 (23.7%)   104   60 (21.4%)   96    124      200   48 (13.8%)   70
                   disorders                                               (22.5%)
                   General disorders   64 (23.7%)   102   45 (16.1%)   80   109      182   50 (14.4%)   62
                   and administration                                      (19.8%)
                   site conditions
                   Hepatobiliary      1 (0.4%)     1     7 (2.5%)   10     8 (1.5%)   11   3 (0.9%)     3
                   disorders
                   Immune system      4 (1.5%)     4     4 (1.4%)    4     8 (1.5%)   8    4 (1.2%)     4
                   disorders
                   Infections and    76 (28.1%)    129   91 (32.5%)   150   167      279   65 (18.7%)   99
                   infestations                                            (30.4%)
                   Injury, poisoning and   32 (11.9%)   44   32 (11.4%)   37   64 (11.6%)   81   32 (9.2%)   43
                   procedural
                   complications
                   Investigations    32 (11.9%)    51    26 (9.3%)   40   58 (10.5%)   91   22 (6.3%)   25
                   Metabolism and    66 (24.4%)    116   52 (18.6%)   88    118      204   37 (10.7%)   53
                   nutrition disorders                                     (21.5%)
                   Musculoskeletal and   49 (18.1%)   75   58 (20.7%)   73   107     148   56 (16.1%)   70
                   connective tissue                                       (19.5%)
                   disorders
                   Neoplasms benign,   6 (2.2%)    8     9 (3.2%)    9    15 (2.7%)   17   6 (1.7%)     7
                   malignant and
                   unspecified (incl
                   cysts and polyps)
                   Nervous system    61 (22.6%)    86   50 (17.9%)   67     111      153   47 (13.5%)   56
                   disorders                                               (20.2%)

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