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. 2016 Nov 20;129(22):2659–2665. doi: 10.4103/0366-6999.193443

Supplementary Table 1.

Patients deviating from the protocol

Center Random number Group Gender Age Type Detailed description
01 053 Trial Male 77 Absence of primary end points Death at the 70th day
01 054 Trial Female 71 Absence of primary end points No assessment of frequency response at 6-month
01 068 Trial Male 57 Absence of primary end points No assessment of frequency response at 6-month
01 069 Control Male 64 Absence of primary end points No assessment of frequency response at 6-month
01 101 Trial Female 64 Absence of primary end points No assessment of perception threshold immediately after operation
01 122 Control Male 55 Absence of primary end points No assessment of perception threshold immediately after operation
01 129 Trial Male 76 Absence of primary end points Death at the 68th day
02 179 Control Female 74 Absence of primary end points No assessment of perception threshold immediately after operation
02 191 Trial Female 60 Absence of primary end points No assessment of perception threshold immediately after operation
02 192 Control Female 54 Absence of primary end points No assessment of perception threshold immediately after operation
03 004 Control Female 73 Absence of primary end points No assessment of perception threshold immediately after operation
04 002 Trial Male 60 Absence of primary end points No assessment of perception threshold immediately after operation
04 015 Trial Male 71 Absence of primary end points No assessment of perception threshold immediately after operation
04 048 Trial Male 79 Absence of primary end points Death at the 162nd day
04 049 Control Male 77 Absence of primary end points No assessment of perception threshold immediately after operation
04 056 Trial Male 51 Absence of primary end points No assessment of perception threshold immediately after operation
04 100 Trial Male 75 Absence of primary end points No assessment of perception threshold immediately after operation
04 107 Control Male 66 Absence of primary end points No assessment of perception threshold immediately after operation
04 138 Trial Male 71 Absence of primary end points No assessment of perception threshold immediately after operation
05 021 Trial Male 78 Absence of primary end points No assessment of perception threshold immediately after operation
05 025 Control Male 70 Absence of primary end points No assessment of perception threshold immediately after operation
05 043 Trial Male 74 Absence of primary end points No assessment of perception threshold immediately after operation
05 052 Control Male 81 Absence of primary end points Death at the 62nd day
05 116 Trial Male 76 Absence of primary end points No assessment of perception threshold immediately after operation
06 203 Trial Female 76 Loss of follow-up 6-month
06 223 Control Female 82 Loss of follow-up 1-month
07 144 Control Male 26 Absence of primary end points No assessment of perception threshold immediately after operation
08 026 Trial Male 26 Absence of primary end points No assessment of perception threshold immediately after operation
08 040 Control Male 81 Absence of primary end points No perception threshold immediately after operation
08 135 Control Male 33 Absence of primary end points No assessment of perception threshold immediately after operation
08 178 Control Male 56 Loss of follow-up 1-, 3-, and 6-month
08 189 Trial Male 80 Loss of follow-up 6-month
09 038 Trial Male 63 Absence of primary end points Death at the 95th day
09 074 Control Male 78 Absence of primary end points No assessment of perception threshold immediately after operation
09 088 Trial Male 50 Absence of primary end points No assessment of perception threshold immediately after operation
09 098 Control Male 56 Absence of primary end points No assessment of perception threshold immediately after operation
09 175 Trial Female 64 Absence of primary end points No assessment of perception threshold immediately after operation
09 188 Trial Male 84 Absence of primary end points No assessment of perception threshold immediately after operation
09 195 Control Male 69 Absence of primary end points No assessment of perception threshold immediately after operation
09 089 Trial Female 77 Loss of follow-up 3- and 6-month
09 168 Control Female 82 Loss of follow-up 6-month
10 117 Trial Male 43 Absence of primary end points No assessment of perception threshold immediately after operation
10 133 Trial Male 76 Absence of primary end points Death at the 126th day
10 153 Control Male 76 Absence of primary end points No assessment of perception threshold immediately after operation
13 029 Control Male 53 Absence of primary end points No assessment of perception threshold immediately after operation
13 046 Trial Male 67 Absence of primary end points No perception threshold immediately after operation
13 104 Control Female 52 Absence of primary end points No assessment of perception threshold immediately after operation
13 216 Trial Female 59 Absence of primary end points No assessment of perception threshold immediately after operation
14 091 Trial Female 64 Loss of follow-up 1-month
14 090 Control Male 56 Absence of primary end points No assessment of perception threshold immediately after operation
14 115 Control Male 76 Absence of primary end points Death at the 75th day
14 197 Control Female 73 Absence of primary end points No pace-making threshold at 6-month after operation; no assessment of frequency response at 6-month

Center - 01: The Second Affiliated Hospital of Zhejiang University School of Medicine; 02: The Affiliated Hospital of Qingdao University Medical College; 03: The First People’s Hospital of Hangzhou; 04: The First Affiliated Hospital of Lanzhou University; 05: The First Affiliated Hospital of Xi’an Jiaotong University; 06: Northern Jiangsu People’s Hospital; 07: The First Affiliated Hospital of Suzhou University; 08: The Second Affiliated Hospital of Nanchang University; 09: Bethune International Peace Hospital of the Chinese PLA; 10: The First Affiliated Hospital of Kunming Medical University; 13: Jilin Province People’s Hospital; 14: Tianjin Chest Hospital.