Safety and efficacy of a single intra-articular injection of a novel enhanced protein solution (JTA-004) compared to hylan G-F 20 in symptomatic knee osteoarthritis: a randomized, double-blind, controlled phase II/III study

Table 2 Demographic characteristics (Full Analysis Set)

		JTA-100/2 (N = 41)	JTA-200/2 (N = 41)	JTA-200/4 (N = 41)	reference (N = 41)	overall (N = 164)
Age (years)	Mean ± SD	64.2 ± 8.0	61.7 ± 7.0	62.9 ± 7.2	61.8 ± 7.7	62.7 ± 7.5
Sex	Male, n (%)	10 (24.4)	17 (41.5)	14 (34.1)	11 (26.8)	52 (31.7)
Sex	Female, n (%)	31 (75.6)	24 (58.5)	27 (65.9)	30 (73.2)	112 (68.3)
Height (m)	Mean ± SD	1.65 ± 0.08	1.68 ± 0.11	1.66 ± 0.10	1.66 ± 0.10	1.66 ± 0.10
Weight (kg)	Mean ± SD	79.4 ± 13.8	83.7 ± 13.9	77.5 ± 13.8	76.2 ± 15.9	79.2 ± 14.5
BMI (kg/m²)	Mean ± SD	29.0 ± 3.9	29.6 ± 3.5	28.0 ± 3.6	27.5 ± 4.2	28.5 ± 3.9
Kellgren-Lawrence grade	II, n (%)	18 (43.9)	23 (56.1)	25 (61.0)	25 (61.0)	91 (55.5)
Kellgren-Lawrence grade	III, n (%)	23 (56.1)	18 (43.9)	16 (39.0)	16 (39.0)	73 (44.5)

BMI body mass index, JTA-100/2 group of patients receiving an injection of JTA-004 with 100 μg clonidine and 20 mg hyaluronic acid, JTA-200/2 group of patients receiving an injection of JTA-004 with 200 μg clonidine and 20 mg hyaluronic acid, JTA-200/4 group of patients receiving an injection of JTA-004 with 200 μg clonidine and 40 mg hyaluronic acid; n (%), number (percentage) of patients; N, total number of patients; reference, group of patients receiving an injection of the reference treatment (hylan G-F 20); SD, standard deviation

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