Table 5.

Sample sizes (N) for individual treatment arms (u=tt or pt) in a future simple randomized start design required to detect a selected set of effect sizes (i.e., differences on the annual rate of decline in ADAS-cog (δ,Δ) = (β^tt − β^pt − β^pt − β^pp)) with a statistical power of 80% from the IUT. 10% subjects are randomized into placebo arm throughout the trial. A correlation of 0.5 (i.e., γ) between the latent intercept and the slope is assumed.

Trial duration (years)	δ = βtt − βpt	Δ = βpt − βpp	N for u=tt	N for u=pt	Total N
1.5	1.0	1.0	460	2301	3067
1.5	1.0	1.5	337	1689	2251
1.5	1.0	2.0	318	1593	2123
1.5	1.0	2.5	317	1589	2117
1.5	1.5	1.0	361	1805	2406
1.5	1.5	1.5	204	1023	1363
1.5	1.5	2.0	159	799	1064
1.5	1.5	2.5	145	725	966
1.5	2.0	1.0	351	1757	2342
1.5	2.0	1.5	167	836	1114
1.5	2.0	2.0	115	576	767
1.5	2.0	2.5	94	470	626
1.5	2.5	1.0	351	1756	2341
1.5	2.5	1.5	157	787	1049
1.5	2.5	2.0	97	486	647
1.5	2.5	2.5	73	368	490
2.0	1.0	1.0	294	1472	1962
2.0	1.0	1.5	213	1065	1420
2.0	1.0	2.0	199	996	1327
2.0	1.0	2.5	198	992	1322
2.0	1.5	1.0	234	1171	1561
2.0	1.5	1.5	130	654	871
2.0	1.5	2.0	101	506	674
2.0	1.5	2.5	91	455	606
2.0	2.0	1.0	229	1146	1527
2.0	2.0	1.5	108	540	720
2.0	2.0	2.0	73	368	490
2.0	2.0	2.5	59	298	396
2.0	2.5	1.0	229	1146	1527
2.0	2.5	1.5	102	513	683
2.0	2.5	2.0	62	313	416
2.0	2.5	2.5	47	235	313
2.5	1.0	1.0	207	1035	1380
2.5	1.0	1.5	148	744	991
2.5	1.0	2.0	138	693	923
2.5	1.0	2.5	138	690	920
2.5	1.5	1.0	165	828	1103
2.5	1.5	1.5	92	460	613
2.5	1.5	2.0	70	354	471
2.5	1.5	2.5	63	318	423
2.5	2.0	1.0	162	812	1082
2.5	2.0	1.5	76	381	507
2.5	2.0	2.0	51	258	343
2.5	2.0	2.5	41	209	277
2.5	2.5	1.0	162	812	1082
2.5	2.5	1.5	72	363	483
2.5	2.5	2.0	44	221	294
2.5	2.5	2.5	33	165	220

(some rows do not add precisely due to the rounding up in each sample size)