Table 6. Secondary outcome comparisons between and within groups (PP population 3rd–25th percentile)

Variable	Observed value			Changed from baseline
	CG (n = 38)	EG (n = 37)	p**	CG (n = 38)	p*	EG (n = 37)	p*	p**
HV (cm/year)
visit 3	7.69 ± 5.80	14.80 ± 12.85	0.0042)
visit 4	6.20 ± 5.42	6.72 ± 5.70	0.7342)
visit 5	5.25 ± 4.55	6.16 ± 4.58	0.3891)
visit 6	6.75 ± 4.45	8.90 ± 4.19	0.0351)
Height SDS
visit 2	–1.19 ± 0.33	–1.12 ± 0.36	0.2802)
visit 3	–1.15 ± 0.37	–0.93 ± 0.44	0.0261)	0.05 ± 0.13	0.0343)	0.19 ± 0.25	<0.0014)	0.0062)
visit 4	–1.13 ± 0.36	–0.90 ± 0.44	0.0161)	0.06 ± 0.12	0.0023)	0.22 ± 0.26	<0.0014)	0.0022)
visit 5	–1.14 ± 0.36	–0.91 ± 0.44	0.0151)	0.06 ± 0.13	0.0123)	0.22 ± 0.27	<0.0014)	0.0012)
visit 6	–1.12 ± 0.36	–0.84 ± 0.42	0.0031)	0.07 ± 0.14	0.0023)	0.29 ± 0.28	<0.0014)	<0.0012)
BA (months)
visit 2	81.42 ± 26.50	94.76 ± 25.24	0.0272)
visit 6	90.32 ± 26.44	103.41 ± 24.03	0.0242)	8.89 ± 6.94	<0.0014)	8.65 ± 10.23	<0.0014)	0.7122)0.9636)
GH (ng/mL)
visit 2	2.41 ± 2.52	2.88 ± 4.11	0.7422)
visit 6	1.71 ± 2.75	1.49 ± 1.68	0.8652)	–0.71 ± 3.52	0.1094)	–1.39 ± 3.63	0.0394)	0.8032)
IGF-1 (ng/mL)
visit 2	186.11 ± 65.44	227.24 ± 116.48	0.1912)
visit 6	171.84 ± 67.14	214.49 ± 99.16	0.0592)	–14.27 ± 29.83	0.0084)	–12.75 ± 47.72	0.1054)	0.8691)
IGFBP-3 (ng/mL)
visit 2	4,530 ± 973	4,711 ± 931	0.4141)
visit 6	4,219 ± 897	4,699 ± 929	0.0261)	–311 ± 527	0.0013)	–11 ± 757	0.9283)	0.1142)
Osteocalcin (ng/mL)
visit 2	58.19 ± 14.81	66.61 ± 21.26	0.0452)
visit 6	75.37 ± 23.73	83.92 ± 21.89	0.0482)	17.18 ± 16.69	<0.0014)	17.31 ± 21.53	<0.0014)	0.9781)0.5875)
DPD (nM/mM.cre)
visit 2	19.20 ± 6.25	18.32 ± 5.80	0.5672)
visit 6	14.83 ± 4.63	15.03 ± 8.37	0.8961)	–4.37 ± 6.41	<0.0013)	–3.29 ± 10.72	0.0844)	0.2192)

p-values were compared within each group.
p-values were compared between groups.
Normality was assessed using the Shapiro–Wilk test
p-values were derived from independent t-test.
p-values were derived from Mann-Whitney U test.
p-values were derived from paired t-test.
p-values were derived from Wilcoxon’s signed rank test.
p-values were derived from ANCOVA.
p-values were derived from ranked ANCOVA (Shapiro-Wilk’s test was employed for test of normality assumption).
PP, per-protocol; CG, control group; EG, experimental group; HV, height velocity; SDS, standard deviation scores; BA, bone age; GH, growth hormone; IGF-1, insulin-like growth factor 1; IGFBP-3, insulin-like growth factor-binding protein 3; DPD, deoxypyridinoline.