Trial Outcomes & Findings for rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency (NCT NCT00572156)

NCT ID: NCT00572156

Last Updated: 2023-03-30

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 106 participants
• Primary outcome timeframe: First year of treatment
• Results posted on: 2023-03-30

Participant Flow

Date of first enrolment: December 2007. Date of last completed: March 2012. This was a Phase II, multicenter, randomized, open-label, parallel-group, active treatment controlled, dose selection study conducted at 27 centers in the US.

Study screened 155 subjects. Due to failure in screening 49 subjects were excluded from the trial before assignment to groups.

Participant milestones

Measure	45 rhGH Alone Nutropin AQ® (Somatropin \[rDNA origin\]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Overall Study STARTED	26	27	27	26
Overall Study COMPLETED	0	1	0	1
Overall Study NOT COMPLETED	26	26	27	25

Reasons for withdrawal

Measure	45 rhGH Alone Nutropin AQ® (Somatropin \[rDNA origin\]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Overall Study Adverse Event	3	1	5	1
Overall Study Lost to Follow-up	1	1	1	0
Overall Study Protocol Violation	1	2	0	2
Overall Study Patient/Parent Decision	1	6	4	3
Overall Study Sponsor Decision	20	16	17	19

Baseline Characteristics

rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency

Baseline characteristics by cohort

Measure	45 rhGH Alone n=26 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection	Total n=106 Participants Total of all reporting groups
Age, Continuous	9.2 years STANDARD_DEVIATION 2.0 • n=5 Participants	8.4 years STANDARD_DEVIATION 2.0 • n=7 Participants	9.0 years STANDARD_DEVIATION 2.2 • n=5 Participants	8.8 years STANDARD_DEVIATION 2.3 • n=4 Participants	8.8 years STANDARD_DEVIATION 2.1 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	22 Participants n=4 Participants	85 Participants n=21 Participants
Race Asian	2 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	8 participants n=21 Participants
Race Black	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Race Hispanic	4 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	10 participants n=21 Participants
Race White	17 participants n=5 Participants	20 participants n=7 Participants	19 participants n=5 Participants	23 participants n=4 Participants	79 participants n=21 Participants
Race Hispanic/White	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Race Hawaiian or Pacific Islander/ White	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Height	-2.5 Standard Deviation Score (SDS) STANDARD_DEVIATION 0.5 • n=5 Participants	-2.5 Standard Deviation Score (SDS) STANDARD_DEVIATION 0.4 • n=7 Participants	-2.6 Standard Deviation Score (SDS) STANDARD_DEVIATION 0.4 • n=5 Participants	-2.6 Standard Deviation Score (SDS) STANDARD_DEVIATION 0.4 • n=4 Participants	-2.5 Standard Deviation Score (SDS) STANDARD_DEVIATION 0.4 • n=21 Participants
Weight	-2.0 SDS STANDARD_DEVIATION 0.7 • n=5 Participants	-2.1 SDS STANDARD_DEVIATION 0.6 • n=7 Participants	-2.0 SDS STANDARD_DEVIATION 0.7 • n=5 Participants	-2.2 SDS STANDARD_DEVIATION 0.9 • n=4 Participants	-2.1 SDS STANDARD_DEVIATION 0.7 • n=21 Participants
Body Mass Index (BMI)	-0.3 SDS STANDARD_DEVIATION 0.7 • n=5 Participants	-0.5 SDS STANDARD_DEVIATION 0.7 • n=7 Participants	-0.4 SDS STANDARD_DEVIATION 0.7 • n=5 Participants	-0.5 SDS STANDARD_DEVIATION 0.8 • n=4 Participants	-0.4 SDS STANDARD_DEVIATION 0.7 • n=21 Participants
IGF-1	-1.8 SDS STANDARD_DEVIATION 0.5 • n=5 Participants	-2.0 SDS STANDARD_DEVIATION 0.7 • n=7 Participants	-1.8 SDS STANDARD_DEVIATION 0.6 • n=5 Participants	-2.0 SDS STANDARD_DEVIATION 0.6 • n=4 Participants	-1.9 SDS STANDARD_DEVIATION 0.6 • n=21 Participants
Mid-Parental target height	-0.5 SDS STANDARD_DEVIATION 0.4 • n=5 Participants	-0.6 SDS STANDARD_DEVIATION 0.5 • n=7 Participants	-0.5 SDS STANDARD_DEVIATION 0.5 • n=5 Participants	-0.5 SDS STANDARD_DEVIATION 0.5 • n=4 Participants	-0.5 SDS STANDARD_DEVIATION 0.5 • n=21 Participants
Bone age imputed	7.6 years STANDARD_DEVIATION 1.7 • n=5 Participants	7.2 years STANDARD_DEVIATION 1.8 • n=7 Participants	7.2 years STANDARD_DEVIATION 2.0 • n=5 Participants	7.3 years STANDARD_DEVIATION 2.0 • n=4 Participants	7.3 years STANDARD_DEVIATION 1.9 • n=21 Participants
Height Age	6.5 years STANDARD_DEVIATION 1.6 • n=5 Participants	6.0 years STANDARD_DEVIATION 1.5 • n=7 Participants	6.4 years STANDARD_DEVIATION 1.8 • n=5 Participants	6.2 years STANDARD_DEVIATION 1.9 • n=4 Participants	6.3 years STANDARD_DEVIATION 1.7 • n=21 Participants
Max stimulated GH	17.9 ng/mL STANDARD_DEVIATION 8.9 • n=5 Participants	18.2 ng/mL STANDARD_DEVIATION 8.4 • n=7 Participants	19.5 ng/mL STANDARD_DEVIATION 6.3 • n=5 Participants	20.1 ng/mL STANDARD_DEVIATION 8.4 • n=4 Participants	18.9 ng/mL STANDARD_DEVIATION 8.0 • n=21 Participants
IGFBP-3 SDS	-1.1 SDS STANDARD_DEVIATION 0.7 • n=5 Participants	-1.2 SDS STANDARD_DEVIATION 0.9 • n=7 Participants	-1.0 SDS STANDARD_DEVIATION 0.8 • n=5 Participants	-1.3 SDS STANDARD_DEVIATION 0.8 • n=4 Participants	-1.1 SDS STANDARD_DEVIATION 0.8 • n=21 Participants
Mother height	157 cm STANDARD_DEVIATION 5 • n=5 Participants	157 cm STANDARD_DEVIATION 5 • n=7 Participants	157 cm STANDARD_DEVIATION 6 • n=5 Participants	159 cm STANDARD_DEVIATION 7 • n=4 Participants	158 cm STANDARD_DEVIATION 6 • n=21 Participants
Father height	172 cm STANDARD_DEVIATION 4 • n=5 Participants	169 cm STANDARD_DEVIATION 5 • n=7 Participants	173 cm STANDARD_DEVIATION 7 • n=5 Participants	172 cm STANDARD_DEVIATION 6 • n=4 Participants	172 cm STANDARD_DEVIATION 6 • n=21 Participants

PRIMARY outcome

Timeframe: First year of treatment

Population: Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement. \[n= 25,27,27,26\]

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Height Velocity	9.3 cm/y Standard Deviation 1.7	10.1 cm/y Standard Deviation 1.3	9.7 cm/y Standard Deviation 2.5	11.2 cm/y Standard Deviation 2.1

SECONDARY outcome

Timeframe: Second, third and fourth year

Population: Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Height Velocity Year 2 height velocity [n= 24,25,22,24]	8.4 cm/y Standard Deviation 1.3	9.1 cm/y Standard Deviation 1.2	9.4 cm/y Standard Deviation 1.6	10.1 cm/y Standard Deviation 1.8
Height Velocity Year 3 height velocity [n= 22,22,20,22]	8.0 cm/y Standard Deviation 1.1	8.4 cm/y Standard Deviation 1.0	8.9 cm/y Standard Deviation 1.3	9.2 cm/y Standard Deviation 1.5
Height Velocity Year 4 height velocity [n= 17,16,15,16]	7.7 cm/y Standard Deviation 0.9	8.1 cm/y Standard Deviation 0.8	8.4 cm/y Standard Deviation 1.2	8.3 cm/y Standard Deviation 1.3

SECONDARY outcome

Timeframe: First, second, third and fourth year

Population: Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.

The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Cumulative Change in Height Standard Deviation Score (SDS) First year [n= 25,27,27,26]	0.7 SDS Standard Deviation 0.3	0.9 SDS Standard Deviation 0.2	0.8 SDS Standard Deviation 0.4	1.0 SDS Standard Deviation 0.4
Cumulative Change in Height Standard Deviation Score (SDS) Second year [n= 24,25,22,24]	1.0 SDS Standard Deviation 0.4	1.4 SDS Standard Deviation 0.4	1.4 SDS Standard Deviation 0.5	1.6 SDS Standard Deviation 0.6
Cumulative Change in Height Standard Deviation Score (SDS) Third year [n=22,22,20,22]	1.3 SDS Standard Deviation 0.5	1.6 SDS Standard Deviation 0.4	1.8 SDS Standard Deviation 0.7	1.9 SDS Standard Deviation 0.6
Cumulative Change in Height Standard Deviation Score (SDS) Fourth year [n=17,16,15,16]	1.5 SDS Standard Deviation 0.5	1.8 SDS Standard Deviation 0.5	2.1 SDS Standard Deviation 0.8	2.0 SDS Standard Deviation 0.7

SECONDARY outcome

Timeframe: At baseline (Day 1), year 1,2,3 and 4

Population: Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).

Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.

The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Predicted Adult Height (PAH) Baseline (day 1) [n=25,27,27,26]	-1.67 SDS Standard Deviation 0.51	-1.83 SDS Standard Deviation 0.58	-1.69 SDS Standard Deviation 0.59	-1.76 SDS Standard Deviation 0.73
Predicted Adult Height (PAH) Year 1 [n= 24,25,22,25]	-1.12 SDS Standard Deviation 0.57	-1.22 SDS Standard Deviation 0.58	-0.99 SDS Standard Deviation 0.55	-1.01 SDS Standard Deviation 0.80
Predicted Adult Height (PAH) Year 2 [n= 22,21,20,22]	-0.96 SDS Standard Deviation 0.56	-0.81 SDS Standard Deviation 0.55	-0.66 SDS Standard Deviation 0.56	-0.69 SDS Standard Deviation 0.91
Predicted Adult Height (PAH) Year 3 [n=21,19,19,20]	-0.78 SDS Standard Deviation 0.63	-0.65 SDS Standard Deviation 0.60	-0.42 SDS Standard Deviation 0.62	-0.64 SDS Standard Deviation 0.98
Predicted Adult Height (PAH) Year 4 [n=3,4,4,3]	-1.22 SDS Standard Deviation 0.59	-0.44 SDS Standard Deviation 0.81	0.49 SDS Standard Deviation 0.60	-0.07 SDS Standard Deviation 0.89
Predicted Adult Height (PAH) Mid-parental target height [n=25,27,27,26]	-0.51 SDS Standard Deviation 0.38	-0.64 SDS Standard Deviation 0.52	-0.53 SDS Standard Deviation 0.50	-0.47 SDS Standard Deviation 0.51

SECONDARY outcome

Timeframe: At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)

Population: Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).

The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Total Change From Baseline (Day 1) in BMI SDS Change from day 1 to visit 23 [n=25,27,27,26]	0.34 SDS Standard Deviation 0.54	0.45 SDS Standard Deviation 0.45	0.42 SDS Standard Deviation 0.53	0.64 SDS Standard Deviation 0.60
Total Change From Baseline (Day 1) in BMI SDS Change from day 1 to year 1 [n= 24,25,22,25]	0.24 SDS Standard Deviation 0.43	0.31 SDS Standard Deviation 0.39	0.36 SDS Standard Deviation 0.41	0.54 SDS Standard Deviation 0.40
Total Change From Baseline (Day 1) in BMI SDS Change from day 1 to year 2 [n= 22,21,20,22]	0.31 SDS Standard Deviation 0.49	0.57 SDS Standard Deviation 0.41	0.49 SDS Standard Deviation 0.44	0.59 SDS Standard Deviation 0.46
Total Change From Baseline (Day 1) in BMI SDS Change from day 1 to year 3 [n=21,19,19,20]	0.35 SDS Standard Deviation 0.58	0.62 SDS Standard Deviation 0.43	0.49 SDS Standard Deviation 0.59	0.71 SDS Standard Deviation 0.54
Total Change From Baseline (Day 1) in BMI SDS Change from day 1 to year 4 [n=3,5,5,4]	0.27 SDS Standard Deviation 0.52	0.64 SDS Standard Deviation 0.58	0.65 SDS Standard Deviation 0.90	1.20 SDS Standard Deviation 0.91

SECONDARY outcome

Timeframe: At baseline(day 1), year 1,2,3 and 4

Population: Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).

Assessed by bone age. Bone age was determined by the radiograph.

The SDS was calculated as: SDS=[(value /M)^L - 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject's age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Skeletal Maturation Baseline [n=25,27,27,26]	7.6 SDS Standard Deviation 1.8	7.3 SDS Standard Deviation 1.9	7.2 SDS Standard Deviation 2.0	7.4 SDS Standard Deviation 2.0
Skeletal Maturation Year 1 [n= 24,25,22,25]	9.0 SDS Standard Deviation 1.9	8.5 SDS Standard Deviation 1.9	8.4 SDS Standard Deviation 2.2	8.5 SDS Standard Deviation 2.1
Skeletal Maturation Year 2 [n= 22,21,20,22]	10.3 SDS Standard Deviation 2.0	9.6 SDS Standard Deviation 2.1	9.8 SDS Standard Deviation 2.4	9.9 SDS Standard Deviation 2.2
Skeletal Maturation Year 3 [n=21,19,19,20]	11.4 SDS Standard Deviation 2.0	10.9 SDS Standard Deviation 2.2	11.4 SDS Standard Deviation 2.4	10.9 SDS Standard Deviation 2.2
Skeletal Maturation Year 4 [n=3,4,5,3]	12.4 SDS Standard Deviation 1.0	10.9 SDS Standard Deviation 1.8	12.2 SDS Standard Deviation 3.0	12.5 SDS Standard Deviation 2.1

SECONDARY outcome

Timeframe: At Baseline (Day 1), Year 1,2,3 and 4

Population: Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH) Day 1 (Baseline) [n=23,25,18,25]	1.1 ng/mL Standard Deviation 2.2	2.9 ng/mL Standard Deviation 8.1	2.4 ng/mL Standard Deviation 4.5	1.9 ng/mL Standard Deviation 2.3
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH) Year 1 (Trough) [n=23,25,18,25]	1.7 ng/mL Standard Deviation 2.1	3.5 ng/mL Standard Deviation 12.9	2.1 ng/mL Standard Deviation 3.2	1.4 ng/mL Standard Deviation 2.1
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH) Year 2 (Trough) [n=21,20,16,20]	4.0 ng/mL Standard Deviation 6.0	2.2 ng/mL Standard Deviation 4.2	2.7 ng/mL Standard Deviation 3.9	1.4 ng/mL Standard Deviation 1.2
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH) Year 3 (Trough) [n=20,18,15,20]	2.8 ng/mL Standard Deviation 5.1	1.3 ng/mL Standard Deviation 1.6	1.5 ng/mL Standard Deviation 1.4	1.9 ng/mL Standard Deviation 3.5
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH) Year 4 (Trough) [n=3,5,4,3]	1.2 ng/mL Standard Deviation 0.3	0.5 ng/mL Standard Deviation 0.4	3.0 ng/mL Standard Deviation 2.9	1.1 ng/mL Standard Deviation 0.6

SECONDARY outcome

Timeframe: At Baseline (Day 1), Year 1,2,3 and 4

Population: Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1) Day 1 (Baseline) [n= 24,25,22,25]	108.3 ng/mL Standard Deviation 39.8	87.1 ng/mL Standard Deviation 31.0	100.2 ng/mL Standard Deviation 41.4	96.7 ng/mL Standard Deviation 38.8
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1) Year 1 (Trough) [n= 24,25,22,25]	278.2 ng/mL Standard Deviation 95.5	326.9 ng/mL Standard Deviation 108.9	397.8 ng/mL Standard Deviation 185.4	296.0 ng/mL Standard Deviation 126.8
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1) Year 2 (Trough) [n= 22,21,20,22]	312.8 ng/mL Standard Deviation 97.2	427.2 ng/mL Standard Deviation 178.5	539.3 ng/mL Standard Deviation 195.9	466.4 ng/mL Standard Deviation 178.6
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1) Year 3 (Trough)[n= 21,19,19, 20]	335.3 ng/mL Standard Deviation 110.0	404.9 ng/mL Standard Deviation 104.4	462.2 ng/mL Standard Deviation 156.4	441.3 ng/mL Standard Deviation 226.0
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1) Year 4 (Trough)[n= 3,5,5,3]	347.7 ng/mL Standard Deviation 130.7	363.6 ng/mL Standard Deviation 125.4	546.2 ng/mL Standard Deviation 265.8	607.7 ng/mL Standard Deviation 65.0

SECONDARY outcome

Timeframe: At Baseline (Day 1), Year 1,2,3 and 4

Population: Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Day 1 (Baseline) [n= 24,24,21,24]	87.8 ng/mL Standard Deviation 54.5	102.5 ng/mL Standard Deviation 37.2	95.7 ng/mL Standard Deviation 50.0	122.4 ng/mL Standard Deviation 53.7
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Year 1 (Trough) [n= 24,24,21,24]	45.7 ng/mL Standard Deviation 38.0	63.8 ng/mL Standard Deviation 50.1	68.2 ng/mL Standard Deviation 61.6	88.8 ng/mL Standard Deviation 47.4
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Year 2 (Trough) [n= 22,21,19,20]	59.4 ng/mL Standard Deviation 45.6	58.2 ng/mL Standard Deviation 47.7	53.3 ng/mL Standard Deviation 35.3	71.7 ng/mL Standard Deviation 46.1
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Year 3 (Trough) [n= 21,19,18,19]	46.1 ng/mL Standard Deviation 35.2	60.4 ng/mL Standard Deviation 52.5	53.2 ng/mL Standard Deviation 34.8	84.7 ng/mL Standard Deviation 53.5
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Year 4 (Trough) [n= 3,5,5,3]	100.0 ng/mL Standard Deviation 60.4	46.8 ng/mL Standard Deviation 58.0	49.2 ng/mL Standard Deviation 20.7	49.0 ng/mL Standard Deviation 26.9

SECONDARY outcome

Timeframe: At Baseline (Day 1), Year 1,2,3 and 4

Population: Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3) Day 1 (Baseline) [n= 24,25,22,25]	2204.2 ng/mL Standard Deviation 387.3	2160.0 ng/mL Standard Deviation 421.3	2113.6 ng/mL Standard Deviation 486.3	2196.0 ng/mL Standard Deviation 612.0
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3) Year 1 (Trough) [n= 24,25,22,25]	2954.2 ng/mL Standard Deviation 618.5	2784.0 ng/mL Standard Deviation 755.9	2677.3 ng/mL Standard Deviation 548.5	2624.0 ng/mL Standard Deviation 598.8
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3) Year 2 (Trough) [n= 22,21,20,22]	2813.6 ng/mL Standard Deviation 399.2	2942.9 ng/mL Standard Deviation 552.8	3060.0 ng/mL Standard Deviation 703.7	2754.5 ng/mL Standard Deviation 600.6
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3) Year 3 (Trough) [n= 21,19,19,20]	3404.8 ng/mL Standard Deviation 476.9	3431.6 ng/mL Standard Deviation 718.1	3373.7 ng/mL Standard Deviation 479.4	3260.0 ng/mL Standard Deviation 908.1
Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3) Year 4 (Trough) [n= 3,5,5,3]	3733.3 ng/mL Standard Deviation 378.6	3260.0 ng/mL Standard Deviation 709.2	3620.0 ng/mL Standard Deviation 957.6	3466.7 ng/mL Standard Deviation 461.9

SECONDARY outcome

Timeframe: At Baseline (Day 1), Year 1,2,3 and 4

Population: Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS) Day 1 (Baseline) [n=25,26,26,25]	10.6 mg/L Standard Deviation 3.0	10.0 mg/L Standard Deviation 3.4	10.9 mg/L Standard Deviation 3.0	11.0 mg/L Standard Deviation 4.1
Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS) Year 1 (Trough) [n=24,24,21,24]	16.0 mg/L Standard Deviation 4.0	12.7 mg/L Standard Deviation 2.3	14.0 mg/L Standard Deviation 3.9	11.5 mg/L Standard Deviation 2.8
Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS) Year 2 (Trough) [n= 22,21,19,20]	15.2 mg/L Standard Deviation 4.3	14.3 mg/L Standard Deviation 5.2	15.7 mg/L Standard Deviation 4.0	13.7 mg/L Standard Deviation 4.5
Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS) Year 3 (Trough) [n= 21,18,18,19]	13.7 mg/L Standard Deviation 2.3	13.0 mg/L Standard Deviation 3.2	12.9 mg/L Standard Deviation 2.7	11.2 mg/L Standard Deviation 4.0
Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS) Year 4 (Trough) [n= 3,5,5,3]	13.7 mg/L Standard Deviation 1.5	12.0 mg/L Standard Deviation 2.2	12.0 mg/L Standard Deviation 3.0	13.7 mg/L Standard Deviation 2.1

SECONDARY outcome

Timeframe: At Baseline (Day 1), Year 1,2,3 and 4

Population: Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.

Outcome measures

Measure	rhGH Alone n=25 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP) Year 3 (Trough) [n= 21,17,17,19]	672.0 pmol/L Standard Deviation 224.4	646.9 pmol/L Standard Deviation 204.1	614.3 pmol/L Standard Deviation 210.9	554.9 pmol/L Standard Deviation 197.0
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP) Day 1 (Baseline) [n= 25,26,25,25]	785.8 pmol/L Standard Deviation 291.1	735.8 pmol/L Standard Deviation 343.5	698.8 pmol/L Standard Deviation 212.2	719.0 pmol/L Standard Deviation 261.5
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP) Year 1 (Trough) [n= 23,24,20,24]	729.4 pmol/L Standard Deviation 229.5	576.9 pmol/L Standard Deviation 211.0	598.9 pmol/L Standard Deviation 187.3	530.5 pmol/L Standard Deviation 233.5
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP) Year 2 (Trough) [n=22,21,18,21]	725.6 pmol/L Standard Deviation 308.4	589.3 pmol/L Standard Deviation 171.6	562.5 pmol/L Standard Deviation 184.4	564.6 pmol/L Standard Deviation 171.9
Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP) Year 4 (Trough) [n= 3,5,5,3]	714.0 pmol/L Standard Deviation 38.5	516.9 pmol/L Standard Deviation 252.5	798.2 pmol/L Standard Deviation 336.1	519.7 pmol/L Standard Deviation 141.1

SECONDARY outcome

Timeframe: Approximately up to 4 years.

Population: Safety population: Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.

A Data Monitoring Committee (DMC) was established to monitor subject safety

Outcome measures

Measure	rhGH Alone n=26 Participants Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	45 rhGH + 50 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	45 rhGH + 100 rhIGF-1 n=27 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	45 rhGH + 150 rhIGF-1 n=26 Participants Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Summary of Adverse Events With Number of Occurrences Related and Mild	21 Number of events	48 Number of events	55 Number of events	106 Number of events
Summary of Adverse Events With Number of Occurrences TEAEs Leading to Study Withdrawal	18 Number of events	17 Number of events	36 Number of events	6 Number of events
Summary of Adverse Events With Number of Occurrences Deaths	0 Number of events	0 Number of events	0 Number of events	0 Number of events
Summary of Adverse Events With Number of Occurrences SAEs	1 Number of events	6 Number of events	2 Number of events	1 Number of events
Summary of Adverse Events With Number of Occurrences Any Adverse Event	381 Number of events	416 Number of events	401 Number of events	518 Number of events
Summary of Adverse Events With Number of Occurrences Any TEAE	374 Number of events	406 Number of events	392 Number of events	513 Number of events
Summary of Adverse Events With Number of Occurrences Severe TEAEs	5 Number of events	5 Number of events	3 Number of events	3 Number of events
Summary of Adverse Events With Number of Occurrences Moderate TEAE	60 Number of events	55 Number of events	57 Number of events	86 Number of events
Summary of Adverse Events With Number of Occurrences Mild TEAE	309 Number of events	346 Number of events	332 Number of events	424 Number of events
Summary of Adverse Events With Number of Occurrences Related TEAEs	27 Number of events	53 Number of events	74 Number of events	119 Number of events
Summary of Adverse Events With Number of Occurrences Related and Severe	1 Number of events	1 Number of events	1 Number of events	0 Number of events
Summary of Adverse Events With Number of Occurrences Related and Moderate	5 Number of events	4 Number of events	18 Number of events	13 Number of events

Adverse Events

1. rhGH Alone

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

2. 45 rhGH + 50 rhIGF-1

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

3. 45 rhGH + 100 rhIGF-1

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

4. 45 rhGH + 150 rhIGF-1

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	1. rhGH Alone n=26 participants at risk Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	2. 45 rhGH + 50 rhIGF-1 n=27 participants at risk Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	3. 45 rhGH + 100 rhIGF-1 n=27 participants at risk Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	4. 45 rhGH + 150 rhIGF-1 n=26 participants at risk Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Nervous system disorders Intracranial pressure increased	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Blood and lymphatic system disorders Evans syndrome	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Viral infection	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Gastroenteritis viral	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Renal and urinary disorders Hematuria	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Eye disorders Papilledema	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.

Other adverse events

Measure	1. rhGH Alone n=26 participants at risk Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg once daily injection	2. 45 rhGH + 50 rhIGF-1 n=27 participants at risk Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections	3. 45 rhGH + 100 rhIGF-1 n=27 participants at risk Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections	4. 45 rhGH + 150 rhIGF-1 n=26 participants at risk Increlex® (Mecasermin \[rDNA origin\] injection) + Nutropin AQ® (Somatropin \[rDNA origin\]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
Infections and infestations Upper respiratory tract infection	38.5% 10/26 • Number of events 23 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	37.0% 10/27 • Number of events 19 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	33.3% 9/27 • Number of events 31 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	50.0% 13/26 • Number of events 37 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Otitis media	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	34.6% 9/26 • Number of events 19 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Viral infection	23.1% 6/26 • Number of events 10 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	22.2% 6/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	30.8% 8/26 • Number of events 21 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Gastroenteritis	3.8% 1/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 9 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	23.1% 6/26 • Number of events 10 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Pharyngitis streptococcal	19.2% 5/26 • Number of events 13 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	44.4% 12/27 • Number of events 17 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	25.9% 7/27 • Number of events 9 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	23.1% 6/26 • Number of events 14 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Gastroenteritis viral	23.1% 6/26 • Number of events 8 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 9 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Influenza	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Ear infection	11.5% 3/26 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Otitis externa	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Molluscum contagiosum	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Bronchitis	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Nasopharyngitis	11.5% 3/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 15 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Pharyngitis	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Sinusitis	19.2% 5/26 • Number of events 25 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	25.9% 7/27 • Number of events 14 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Urinary tract infection	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Varicella	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Tonsillitis	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Viral upper respiratory tract infection	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Vomiting	34.6% 9/26 • Number of events 17 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	22.2% 6/27 • Number of events 12 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	46.2% 12/26 • Number of events 19 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Infections and infestations Abdominal pain upper	26.9% 7/26 • Number of events 11 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 8 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	26.9% 7/26 • Number of events 11 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	23.1% 6/26 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Nausea	15.4% 4/26 • Number of events 10 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	23.1% 6/26 • Number of events 11 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Abdominal pain	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Dyspepsia	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Stomach discomfort	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Abdominal discomfort	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Gastrointestinal disorders Toothache	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Pyrexia	34.6% 9/26 • Number of events 17 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	55.6% 15/27 • Number of events 27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 22 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	50.0% 13/26 • Number of events 19 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Injection site pain	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	15.4% 4/26 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Malaise	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Injection site bruising	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Injection site hypertrophy	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	22.2% 6/27 • Number of events 8 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	25.9% 7/27 • Number of events 13 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Injection site induration	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Influenza like illness	3.8% 1/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Injection site erythema	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Injection site urticaria	7.7% 2/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Fatigue	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
General disorders Feeling hot	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Nervous system disorders Headache	53.8% 14/26 • Number of events 40 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	51.9% 14/27 • Number of events 43 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	63.0% 17/27 • Number of events 39 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	69.2% 18/26 • Number of events 50 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Nervous system disorders Dizziness	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Nervous system disorders Migraine	3.8% 1/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Nervous system disorders Tremor	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Dermatitis contact	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Urticaria	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Eczema	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Procedural pain	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Contusion	7.7% 2/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Skin laceration	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Upper limb fracture	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Concussion	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Joint sprain	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Limb injury	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Injury, poisoning and procedural complications Orthodontic appliance complication	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Cough	23.1% 6/26 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	51.9% 14/27 • Number of events 18 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	33.3% 9/27 • Number of events 16 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	38.5% 10/26 • Number of events 14 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	25.9% 7/27 • Number of events 11 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	25.9% 7/27 • Number of events 10 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	19.2% 5/26 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 6 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 2/26 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	11.5% 3/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Metabolism and nutrition disorders Hypoglycemia	7.7% 2/26 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	26.9% 7/26 • Number of events 8 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Arthralgia	26.9% 7/26 • Number of events 8 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	23.1% 6/26 • Number of events 12 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 4/26 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	29.6% 8/27 • Number of events 11 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	25.9% 7/27 • Number of events 8 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	19.2% 5/26 • Number of events 12 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Back pain	11.5% 3/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	18.5% 5/27 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	15.4% 4/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Musculoskeletal and connective tissue disorders Myalgia	3.8% 1/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Immune system disorders Hypersensitivity	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Immune system disorders Seasonal allergy	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Eye disorders Eye pain	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Eye disorders Myopia	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Eye disorders Vision blurred	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Eye disorders Conjunctivitis	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	14.8% 4/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Investigations Insulin-like growth factor increased	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Investigations Body temperature increased	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 4 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Investigations Hepatic enzyme increased	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Investigations Thyroxine free decreased	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Investigations Weight decreased	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	15.4% 4/26 • Number of events 5 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Reproductive system and breast disorders Gynaecomastia	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Psychiatric disorders Anxiety	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Psychiatric disorders Affective disorder	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Psychiatric disorders Attention	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Ear and labyrinth disorders Ear pain	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Blood and lymphatic system disorders Lymphadenopathy	15.4% 4/26 • Number of events 7 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	11.1% 3/27 • Number of events 3 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Cardiac disorders Tachycardia	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.7% 2/26 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Renal and urinary disorders Enuresis	3.8% 1/26 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	3.7% 1/27 • Number of events 1 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.
Renal and urinary disorders Pollakiuria	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/27 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	7.4% 2/27 • Number of events 2 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.	0.00% 0/26 • Approximate up to 4 years Treatment emergent adverse event (TEAEs) Reported in ≥5% Subjects Receiving rhGH Alone or Receiving Combination Therapy. Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.

Additional Information

Medical Director, Endocrinology

Ipsen

Phone: clinical.trials@ipsen.com

Email: clinical.trials@ipsen.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60