Common use of Table II Clause in Contracts

Table II. Objective and subjective voice frequency and virilizing adverse events per dosage group. GH+Pl GH+Ox GH+Ox GH+Ox 0.06 GH+Ox (N = 30) 0.03 0.03 vs. (N = 27) 0.06 vs. Outcome (N = 31) GH+Pl GH+Pl P Value P Value Voice frequency at starting Ox/Pl (all age groups) – SDS†‡ Age group 1 (after previous GH therapy) – SDS† 1.1±1.2** 0.6±1.2 0.9±1.4** 0.4±1.6 1.0±0.9** 1.0±1.0 Age groups 2 and 3 (at baseline) – SDS† 1.2±1.2** 1.1±1.4** 1.0±0.9** Change in voice frequency during Ox/Pl (all age groups) – SDS/yr, SE§ -0.05, 0.05 -0.17, 0.05 0.09 -0.27, 0.06 0.007 Age group 1 (after previous GH therapy) – SDS/yr, SE -0.02, 0.08 -0.13, 0.09 0.3 -0.29, 0.10 0.04 Age groups 2 and 3 – SDS/yr, SE -0.06, 0.07 -0.21, 0.06 0.1 -0.22, 0.09 0.2 Change in voice frequency during Ox/Pl without outliers – SDS/yr, SE¶ -0.07, 0.05 -0.16, 0.05 0.2 -0.26, 0.06 0.02 Voice frequency at the last measurement – SDS 0.6±0.7** 0.3±1.2 0.4 -0.2±1.6 0.06 Girls reporting subjective voice deepening – n (%) 10 (33%) 13 (42%) 0.5 14 (52%) 0.2 Girls reporting virilization other than voice deepening during Ox/Pl – n (%)║ 1 (3%) 5 (16%) 0.2 8 (30%) 0.01 Hirsutism 1 (3%) 4 (13%) 0.4 8 (30%) 0.01 Mild clitoromegaly 0 (0%) 4 (13%) 0.1 4 (15%) 0.04 * values are expressed as means±SD, unless otherwise indicated. † No statistical tests were applied to assess differences between the dosage groups at starting Ox/Pl. ‡ Based on 18, 19 and 11 tests in GH+Pl, GH+Ox 0.03 and GH+Ox 0.06, respectively. These recordings were included in repeated measurements analyses, which takes into account missing data. § Based on 123, 149 and 92 tests during Ox/Pl and 20, 26, 21 tests at the last measurement (i.e. at or after discontinuation of Ox/Pl) in GH+Pl, GH+Ox 0.03 and GH+Ox 0.06, respectively. ¶ Five voice recordings (of two girls) that displayed a voice frequency higher than 4.5 SDS were identiefied as outliers. ║ Some patients reported hirsutism as well as clitoromegaly, while others reported only one these complaints. The number of the patients reporting both adverse event may therefore not equal the numbers in this row. ** Significantly different from 0 SDS (i.e. from healthy Dutch girls, P<0.05). GH+Pl GH+Ox 0.03 GH+Ox 0.06 60 50 % of patients 40 10 0 voice voice breaks hoarseness voice has voice has voice has nasal sound deepening become become become softer higher louder