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. 2014 Apr 22;6:78. doi: 10.3389/fnagi.2014.00078

Table 4.

Estimated required sample size (right side) for a two-arm phase II randomized clinical trial.

Variable Type Dropout (%) Estimated parameters
Effect size
βS g11 g12 g22 σe2 20% 30% 40% 50% 60% 70%
CSF Imaging 0 4.094 486.882 5.189 3.183 53.737 332 147 83 53 37 27
CSF Imaging 10 4.094 486.882 5.189 3.183 53.737 357 159 89 57 40 29
CSF Imaging 20 4.094 486.882 5.189 3.183 53.737 386 172 97 62 43 32
Putamen Imaging 0 −0.100 0.810 −0.004 0.003 0.037 391 174 98 63 43 32
Putamen Imaging 10 −0.100 0.810 −0.004 0.003 0.037 421 187 105 67 47 34
Putamen Imaging 20 −0.100 0.810 −0.004 0.003 0.037 455 202 114 73 51 37
Caudate Imaging 0 −0.111 0.666 0.005 0.003 0.078 628 279 157 101 70 51
Caudate Imaging 10 −0.111 0.666 0.005 0.003 0.078 676 301 169 108 75 55
Caudate Imaging 20 −0.111 0.666 0.005 0.003 0.078 732 325 183 117 81 60
TMS Motor 0 1.498 21.338 5.008 3.050 16.789 981 436 245 157 109 80
TMS Motor 10 1.498 21.338 5.008 3.050 16.789 1051 467 263 168 117 86
TMS Motor 20 1.498 21.338 5.008 3.050 16.789 1131 503 283 181 126 92
Sp-Tapping Cognitive 0 7.345 3255.107 296.690 72.380 554.870 1230 546 307 197 137 100
Sp-Tapping Cognitive 10 7.345 3255.107 296.690 72.380 554.870 1318 586 330 211 146 108
Sp-Tapping Cognitive 20 7.345 3255.107 296.690 72.380 554.870 1421 632 355 227 158 116
Hippocampus Imaging 0 −0.022 0.066 0.000 0.000 0.006 1322 588 330 212 147 108
Hippocampus Imaging 10 −0.022 0.066 0.000 0.000 0.006 1422 632 356 228 158 116
Hippocampus Imaging 20 −0.022 0.066 0.000 0.000 0.006 1540 684 385 246 171 126
Chorea Motor 0 0.480 1.383 0.401 0.335 2.675 1373 610 343 220 153 112
Chorea Motor 10 0.480 1.383 0.401 0.335 2.675 1472 654 368 236 164 120
Chorea Motor 20 0.480 1.383 0.401 0.335 2.675 1586 705 397 254 176 130
Brady Motor 0 0.520 4.748 0.811 0.438 3.305 1467 652 367 235 163 120
Brady Motor 10 0.520 4.748 0.811 0.438 3.305 1574 699 393 252 175 128
Brady Motor 20 0.520 4.748 0.811 0.438 3.305 1698 754 424 272 189 139
Dysrhythmia Cognitive 0 3.002 592.124 53.942 12.919 135.291 1676 745 419 268 186 137
Dysrhythmia Cognitive 10 3.002 592.124 53.942 12.919 135.291 1801 800 450 288 200 147
Dysrhythmia Cognitive 20 3.002 592.124 53.942 12.919 135.291 1945 864 486 311 216 159
Thalamus Imaging 0 −0.058 0.316 −0.006 0.003 0.069 2077 923 519 332 231 170
Thalamus Imaging 10 −0.058 0.316 −0.006 0.003 0.069 2230 991 557 357 248 182
Thalamus Imaging 20 −0.058 0.316 −0.006 0.003 0.069 2407 1070 602 385 267 197
TFC Functional 0 −0.156 0.518 0.038 0.054 0.551 2540 1129 635 406 282 207
TFC Functional 10 −0.156 0.518 0.038 0.054 0.551 2722 1210 680 435 302 222
TFC Functional 20 −0.156 0.518 0.038 0.054 0.551 2932 1303 733 469 326 239
SDMT Cognitive 0 −0.906 124.336 0.742 0.904 20.943 2547 1132 637 408 283 208
SDMT Cognitive 10 −0.906 124.336 0.742 0.904 20.943 2740 1218 685 438 304 224
SDMT Cognitive 20 −0.906 124.336 0.742 0.904 20.943 2964 1317 741 474 329 242

Effect size is the percentage difference in rate of change (slope) of the treated and untreated groups (see Supplementary Material). CSF, cerebral spinal fluid; TMS, total motor score; SP-Tapping, speeded tapping; Brady, bradykinesia; TFC, total functional capacity; SDMT, Symbol Digit Modalities Test.