Table 11.

Linear regression of repeated measure (MMRM) analysis of secondary endpoints: Cpk analysis of absolute variation in serum levels (T24wk-baseline/baseline), 6MWT analysis of ΔT24wk-baseline meters walked, and performance scale analysis of ΔT24wk-baseline score.

	DMD		OD
CpK (U/L)	Placebo	FLAVOMEGA	Placebo	FLAVOMEGA
Patients (N=)	5	7	9	6
Mean baseline	1051.00 ± 693.17	2402.29 ± 1146.79	627.00 ± 185.03	639.36 ± 642.84
Mean T 24wk (N=)	1199.40 ± 500.82 (5)	1320.71 ± 711.07 (7)	423.71 ± 206.05 (7)	397.97 ± 214.12 (5)
coefficient + SEM	−0.634	0.161	−0.022	0.289
P-value 95% CI	0.003*	−0.99 ± -0.270	0.94	−0.665 ± 0.621
6MWT (m)
Patients (N=)	Np	Np	7	4
Mean baseline	Np	Np	313.57 ± 214.19	568.25 ± 130.76
Mean T 24 wk (N)	Np	Np	306.71 ± 180.96	591.5 ± 102.18
coefficient + SEM	Np	Np	78.04	30.54
P-value 95% CI	Np	Np	0.033*	7.61 ± 148.47
ACTIVLIM
Patients (N=)	5	7	7	5
Mean baseline	6.2 ± 9.60	2.85 ± 4.33	24.71 ± 7.52	28.2 ± 10.82
Mean T 24 wk (N)	2.6 ± 3.71	3.28 ± 4.85	23.82 ± 7.11	26.8 ± 13.55
coefficient + SEM	2.54	1.41	−1	4.95E-16
P-value 95% CI	0.105	−0.655 ± 5.72	9.06E-135	−1 ±−1
ABILHAND
Patients (N=)	5	7	7	5
Mean baseline	13.8 ± 12.27	15 ± 13.03	33.71 ± 2.36	28.6 ± 11.12
Mean T 24 wk (N)	9.8 ± 9.09	14 ± 11.07	34 ± 1.63	30.6 ± 7.46
coefficient + SEM	3.51	4.47	−0.51	1.75
P-value 95% CI	0.453	−6.600 ± 13.61	0.779	−4.452 ± 3.44
EK
Patients (N=)	5	7	7	5
Mean baseline	16.6 ± 6.8	17 ± 3.91	28 ± 2.08	27.2 ± 4.65
Mean T 24 wk (N)	18 ± 7.31	15.85 ± 5.89	28.42 ± 1.39	28.2 ± 3.03
coefficient + SEM	−2.553	2.243	0.281	0.330
P-value 95% CI	0.285	−7.62 ± 2.52	0.417	−0.465 ± 1.027

^*statistically significant.

CI, Confidence Interval. coefficient + SEM, Regression coefficient + Standard Error of the Mean.