Trial Outcomes & Findings for Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. (NCT NCT02229851)

Results Overview

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

301 participants

Primary outcome timeframe

Week -3, week 34

Results posted on

2020-11-23

Participant Flow

The trial was conducted at 92 sites in 16 countries: Australia - 8, Germany - 4, India - 5, Japan - 14, Latvia - 1, Lithuania - 2, Malaysia - 3, Poland - 5, Romania - 5, Russian Fed. - 6, South Africa - 3, Sweden - 1, Turkey - 4, Ukraine - 1, United Kingdom - 4, United States - 26.

The trial had a main phase and an extension phase. Participants were treated for 34 weeks in the main phase (followed by 1 week washout) and for 52 weeks in the extension phase (followed by 1 week washout).300 participants received treatment;1 participant was randomised but didn't receive any treatment and was therefore not included in any analyses

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Placebo/Somapacitan Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Somapacitan/Somapacitan Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/Norditropin Participants who received Norditropin in the main phase were randomised 1:1 to continue with norditropin or switch to somapacitan. Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main phase were randomised 1:1 to continue with Norditropin or switch to somapacitan. Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Main Phase (Double-blind Phase) STARTED	61	119	120	0	0	0	0
Main Phase (Double-blind Phase) Full Analysis Set	61	119	120	0	0	0	0
Main Phase (Double-blind Phase) Safety Analysis Set	61	119	120	0	0	0	0
Main Phase (Double-blind Phase) COMPLETED	55	103	114	0	0	0	0
Main Phase (Double-blind Phase) NOT COMPLETED	6	16	6	0	0	0	0
Extension Phase (Open-label Phase) STARTED	0	0	0	55	114	52	51
Extension Phase (Open-label Phase) COMPLETED	0	0	0	53	109	47	48
Extension Phase (Open-label Phase) NOT COMPLETED	0	0	0	2	5	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Placebo/Somapacitan Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Somapacitan/Somapacitan Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/Norditropin Participants who received Norditropin in the main phase were randomised 1:1 to continue with norditropin or switch to somapacitan. Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main phase were randomised 1:1 to continue with Norditropin or switch to somapacitan. Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.
Main Phase (Double-blind Phase) Unclassified	1	2	0	0	0	0	0
Main Phase (Double-blind Phase) Lost to Follow-up	0	1	0	0	0	0	0
Main Phase (Double-blind Phase) Withdrawal by Subject	4	12	4	0	0	0	0
Main Phase (Double-blind Phase) Protocol Violation	0	0	2	0	0	0	0
Main Phase (Double-blind Phase) Death	1	1	0	0	0	0	0
Extension Phase (Open-label Phase) Lost to Follow-up	0	0	0	0	1	1	1
Extension Phase (Open-label Phase) Withdrawal by Subject	0	0	0	1	4	3	1
Extension Phase (Open-label Phase) Death	0	0	0	1	0	1	1

Baseline Characteristics

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants received Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants were re-randomised to receive somapacitan while other continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension part of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Total n=300 Participants Total of all reporting groups
Age, Continuous	45.0 Years STANDARD_DEVIATION 15.7 • n=5 Participants	45.7 Years STANDARD_DEVIATION 15.3 • n=7 Participants	44.6 Years STANDARD_DEVIATION 14.3 • n=5 Participants	45.1 Years STANDARD_DEVIATION 15.0 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	61 Participants n=7 Participants	62 Participants n=5 Participants	155 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	58 Participants n=7 Participants	58 Participants n=5 Participants	145 Participants n=4 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants	36 Participants n=7 Participants	34 Participants n=5 Participants	86 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	76 Participants n=7 Participants	82 Participants n=5 Participants	200 Participants n=4 Participants
Race/Ethnicity, Customized Other: Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other: Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other: Caucasian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not applicable	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	57 Participants n=5 Participants	109 Participants n=7 Participants	114 Participants n=5 Participants	280 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Truncal Fat Percentage (Week 34)	0.49 Percentage of truncal fat Standard Deviation 3.31	-2.39 Percentage of truncal fat Standard Deviation 4.48	-1.17 Percentage of truncal fat Standard Deviation 2.89	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Truncal Fat Percentage (Week 87)	-2.16 Percentage of truncal fat Standard Deviation 3.94	-1.63 Percentage of truncal fat Standard Deviation 3.65	-2.63 Percentage of truncal fat Standard Deviation 4.65	-0.96 Percentage of truncal fat Standard Deviation 4.51	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Truncal Fat Mass (Week 34)	417.86 grams Standard Deviation 1536.36	-619.67 grams Standard Deviation 1887.50	-180.98 grams Standard Deviation 1762.31	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Truncal Fat Mass (Week 87)	-311.85 grams Standard Deviation 1771.78	-196.18 grams Standard Deviation 2249.21	-685.56 grams Standard Deviation 2258.93	364.08 grams Standard Deviation 2548.85	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Truncal Lean Body Mass (Week 34)	402.69 grams Standard Deviation 1247.67	832.77 grams Standard Deviation 1409.74	800.27 grams Standard Deviation 1377.75	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Truncal Lean Body Mass (Week 87)	1197.30 grams Standard Deviation 1500.56	1152.79 grams Standard Deviation 1480.06	975.79 grams Standard Deviation 1258.62	1015.12 grams Standard Deviation 1554.88	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Total Fat Mass (Week 34)	305.47 grams Standard Deviation 2689.06	-855.71 grams Standard Deviation 3167.06	-85.47 grams Standard Deviation 3022.71	—	—

SECONDARY outcome

Timeframe: Week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Total Fat Mass (Week 87)	-540.04 grams Standard Deviation 3250.16	-118.07 grams Standard Deviation 3795.36	-923.01 grams Standard Deviation 4099.45	874.56 grams Standard Deviation 4789.34	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=104 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=105 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Visceral Adipose Tissue (Week 34)	4.41 centimeter square Standard Deviation 13.81	-9.68 centimeter square Standard Deviation 21.37	-11.61 centimeter square Standard Deviation 23.93	—	—

SECONDARY outcome

Timeframe: Week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=97 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=40 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=43 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Visceral Adipose Tissue (Week 87)	-9.34 centimeter square Standard Deviation 25.67	-6.71 centimeter square Standard Deviation 33.07	-5.17 centimeter square Standard Deviation 20.11	-5.97 centimeter square Standard Deviation 28.86	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=114 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Android Fat Mass (Week 34)	56.32 gram Standard Deviation 293.93	-158.98 gram Standard Deviation 325.35	-81.52 gram Standard Deviation 361.62	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=107 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=47 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Android Fat Mass (Week 87)	-107.16 gram Standard Deviation 367.14	-39.76 gram Standard Deviation 481.66	-100.76 gram Standard Deviation 386.24	11.52 gram Standard Deviation 489.85	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=114 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Gynoid Fat Mass (Week 34)	8.35 gram Standard Deviation 567.04	-128.59 gram Standard Deviation 471.00	22.66 gram Standard Deviation 510.45	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=107 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=47 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Gynoid Fat Mass (Week 87)	-92.00 gram Standard Deviation 759.37	10.23 gram Standard Deviation 557.20	-100.97 gram Standard Deviation 620.16	140.02 gram Standard Deviation 790.74	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Appendicular Skeletal Muscle Mass (Week 34)	-76.22 gram Standard Deviation 1006.58	482.76 gram Standard Deviation 1246.89	565.21 gram Standard Deviation 1011.18	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Appendicular Skeletal Muscle Mass (Week 87)	447.96 gram Standard Deviation 1688.08	538.45 gram Standard Deviation 1224.13	464.75 gram Standard Deviation 1513.96	632.18 gram Standard Deviation 1928.68	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Lean Body Mass (Week 34)	334.43 gram Standard Deviation 2048.01	1359.33 gram Standard Deviation 2359.11	1395.88 gram Standard Deviation 2139.32	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Lean Body Mass (Week 87)	1717.15 gram Standard Deviation 2965.23	1719.87 gram Standard Deviation 2515.90	1464.51 gram Standard Deviation 2439.75	1681.82 gram Standard Deviation 3413.61	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Bone Mineral Content (Week 87)	-25.61 gram Standard Deviation 93.35	5.02 gram Standard Deviation 113.81	-10.18 gram Standard Deviation 99.18	32.33 gram Standard Deviation 87.86	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Bone Mineral Density (Week 87)	-0.01 grams per square centimeter Standard Deviation 0.04	-0.00 grams per square centimeter Standard Deviation 0.04	-0.00 grams per square centimeter Standard Deviation 0.04	0.01 grams per square centimeter Standard Deviation 0.04	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in IGF-I SDS (Week 34)	0.05 Standard deviation score Standard Deviation 0.59	2.28 Standard deviation score Standard Deviation 1.32	2.37 Standard deviation score Standard Deviation 1.33	—	—

SECONDARY outcome

Timeframe: Week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=47 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in IGF-I SDS (Week 87)	2.36 Standard deviation score Standard Deviation 1.55	2.29 Standard deviation score Standard Deviation 1.39	2.07 Standard deviation score Standard Deviation 1.12	2.35 Standard deviation score Standard Deviation 1.54	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in IGFBP 3 SDS (Week 34)	0.12 Standard deviation score Standard Deviation 0.61	1.44 Standard deviation score Standard Deviation 1.17	1.56 Standard deviation score Standard Deviation 1.24	—	—

SECONDARY outcome

Timeframe: Week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=47 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in IGFBP 3 SDS (Week 87)	1.33 Standard deviation score Standard Deviation 1.20	1.41 Standard deviation score Standard Deviation 1.20	1.30 Standard deviation score Standard Deviation 1.08	1.47 Standard deviation score Standard Deviation 1.51	—

SECONDARY outcome

Timeframe: Week 0, week 34

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in TRIM-AGHD (Total and Domain Scores) (Week 34) Energy	-3.96 Scores on a scale Standard Deviation 25.40	-13.42 Scores on a scale Standard Deviation 23.73	-7.81 Scores on a scale Standard Deviation 24.07	—	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 34) Psychological	-3.38 Scores on a scale Standard Deviation 12.15	-8.93 Scores on a scale Standard Deviation 14.21	-4.63 Scores on a scale Standard Deviation 12.01	—	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 34) Cognitive	-2.25 Scores on a scale Standard Deviation 18.17	-7.06 Scores on a scale Standard Deviation 18.47	-3.92 Scores on a scale Standard Deviation 17.29	—	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 34) Physical	-5.88 Scores on a scale Standard Deviation 14.72	-11.33 Scores on a scale Standard Deviation 19.23	-7.39 Scores on a scale Standard Deviation 19.25	—	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 34) Total	-3.65 Scores on a scale Standard Deviation 12.05	-9.99 Scores on a scale Standard Deviation 13.64	-5.71 Scores on a scale Standard Deviation 12.69	—	—

SECONDARY outcome

Timeframe: week 0, week 87

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in TRIM-AGHD (Total and Domain Scores) (Week 87) Energy	-11.73 Scores on scale Standard Deviation 30.87	-8.11 Scores on scale Standard Deviation 25.46	-23.30 Scores on scale Standard Deviation 28.03	-9.13 Scores on scale Standard Deviation 26.98	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 87) Psychological	-6.97 Scores on scale Standard Deviation 16.05	-6.64 Scores on scale Standard Deviation 14.56	-15.64 Scores on scale Standard Deviation 15.36	-7.35 Scores on scale Standard Deviation 10.50	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 87) Cognitive	-4.88 Scores on scale Standard Deviation 21.19	-5.55 Scores on scale Standard Deviation 18.59	-14.18 Scores on scale Standard Deviation 20.29	-7.71 Scores on scale Standard Deviation 14.14	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 87) Physical	-11.19 Scores on scale Standard Deviation 20.13	-9.57 Scores on scale Standard Deviation 21.94	-17.22 Scores on scale Standard Deviation 27.02	-13.54 Scores on scale Standard Deviation 18.02	—
Change in TRIM-AGHD (Total and Domain Scores) (Week 87) Total	-8.28 Scores on scale Standard Deviation 15.88	-7.25 Scores on scale Standard Deviation 14.42	-17.38 Scores on scale Standard Deviation 16.77	-8.67 Scores on scale Standard Deviation 11.73	—

SECONDARY outcome

Timeframe: Week 0, week 34

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Physical functioning	2.19 Scores on scale Standard Deviation 6.44	2.46 Scores on scale Standard Deviation 7.08	3.18 Scores on scale Standard Deviation 7.67	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Role limitations due to physical health	2.49 Scores on scale Standard Deviation 7.68	3.95 Scores on scale Standard Deviation 8.48	3.14 Scores on scale Standard Deviation 9.06	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Role limitations due to emotional health	2.29 Scores on scale Standard Deviation 9.52	3.50 Scores on scale Standard Deviation 10.87	3.06 Scores on scale Standard Deviation 11.60	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Vitality	3.21 Scores on scale Standard Deviation 7.67	5.26 Scores on scale Standard Deviation 9.89	2.38 Scores on scale Standard Deviation 8.56	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Role limitations due to mental health	0.85 Scores on scale Standard Deviation 9.59	3.72 Scores on scale Standard Deviation 10.17	2.78 Scores on scale Standard Deviation 9.56	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Social functioning	0.10 Scores on scale Standard Deviation 10.43	3.19 Scores on scale Standard Deviation 9.80	2.87 Scores on scale Standard Deviation 9.69	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Bodily pain	0.63 Scores on scale Standard Deviation 8.79	2.19 Scores on scale Standard Deviation 9.50	1.79 Scores on scale Standard Deviation 9.52	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) General health	1.50 Scores on scale Standard Deviation 7.25	4.47 Scores on scale Standard Deviation 7.64	1.85 Scores on scale Standard Deviation 7.58	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Overall physical	2.01 Scores on scale Standard Deviation 6.22	2.87 Scores on scale Standard Deviation 6.33	2.40 Scores on scale Standard Deviation 6.53	—	—
Change in SF-36v2 (Summary and Domain Scores) (Week 34) Overall mental	1.28 Scores on scale Standard Deviation 8.72	4.09 Scores on scale Standard Deviation 10.19	2.70 Scores on scale Standard Deviation 9.29	—	—

SECONDARY outcome

Timeframe: week 0, week 87

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Physical functioning	2.87 Score on scale Standard Deviation 8.13	3.83 Score on scale Standard Deviation 7.66	3.43 Score on scale Standard Deviation 6.96	1.84 Score on scale Standard Deviation 8.07	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Role limitations due to physical health	3.31 Score on scale Standard Deviation 9.81	4.16 Score on scale Standard Deviation 10.10	4.65 Score on scale Standard Deviation 10.06	2.45 Score on scale Standard Deviation 10.50	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Role limitations due to emotional health	3.46 Score on scale Standard Deviation 11.59	3.46 Score on scale Standard Deviation 12.25	7.30 Score on scale Standard Deviation 13.46	1.13 Score on scale Standard Deviation 11.20	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Vitality	6.71 Score on scale Standard Deviation 11.01	4.18 Score on scale Standard Deviation 9.30	8.16 Score on scale Standard Deviation 12.77	4.16 Score on scale Standard Deviation 8.88	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Role limitations due to mental health	2.80 Score on scale Standard Deviation 10.55	3.66 Score on scale Standard Deviation 8.12	6.12 Score on scale Standard Deviation 13.02	1.70 Score on scale Standard Deviation 10.31	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Social functioning	3.84 Score on scale Standard Deviation 10.36	3.44 Score on scale Standard Deviation 10.29	4.56 Score on scale Standard Deviation 10.34	0.57 Score on scale Standard Deviation 11.26	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Bodily pain	1.41 Score on scale Standard Deviation 8.57	1.47 Score on scale Standard Deviation 10.29	3.51 Score on scale Standard Deviation 9.57	0.30 Score on scale Standard Deviation 11.25	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) General health	3.46 Score on scale Standard Deviation 7.33	3.32 Score on scale Standard Deviation 7.70	5.66 Score on scale Standard Deviation 9.67	2.20 Score on scale Standard Deviation 8.66	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Overall physical score	2.66 Score on scale Standard Deviation 6.91	2.98 Score on scale Standard Deviation 7.24	3.06 Score on scale Standard Deviation 7.07	1.81 Score on scale Standard Deviation 7.72	—
Change in SF-36v2 (Summary and Domain Scores) (Week 87) Overall mental score	4.51 Score on scale Standard Deviation 10.39	3.56 Score on scale Standard Deviation 9.06	7.50 Score on scale Standard Deviation 13.59	1.66 Score on scale Standard Deviation 10.18	—

SECONDARY outcome

Timeframe: Week 34

Population: Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.

Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
TSQM-9 Scores (Domain Scores) (Week 34) Effectiveness	49.6 Scores on a scale Standard Deviation 22.2	67.1 Scores on a scale Standard Deviation 21.8	56.1 Scores on a scale Standard Deviation 22.5	—	—
TSQM-9 Scores (Domain Scores) (Week 34) Convenience	74.3 Scores on a scale Standard Deviation 16.9	73.9 Scores on a scale Standard Deviation 18.7	77.7 Scores on a scale Standard Deviation 15.3	—	—
TSQM-9 Scores (Domain Scores) (Week 34) Global satisfaction	54.0 Scores on a scale Standard Deviation 24.8	69.0 Scores on a scale Standard Deviation 24.0	63.1 Scores on a scale Standard Deviation 24.2	—	—

SECONDARY outcome

Timeframe: Week 87

Population: Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.

Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
TSQM-9 Scores (Domain Scores) (Week 87) Convenience	75.1 Scores on a scale Standard Deviation 19.1	80.0 Scores on a scale Standard Deviation 16.5	72.6 Scores on a scale Standard Deviation 20.0	79.4 Scores on a scale Standard Deviation 17.1	—
TSQM-9 Scores (Domain Scores) (Week 87) Global satisfaction	63.2 Scores on a scale Standard Deviation 26.2	68.1 Scores on a scale Standard Deviation 24.6	71.7 Scores on a scale Standard Deviation 25.3	75.1 Scores on a scale Standard Deviation 23.6	—
TSQM-9 Scores (Domain Scores) (Week 87) Effectiveness	59.7 Scores on a scale Standard Deviation 23.1	65.7 Scores on a scale Standard Deviation 22.4	69.6 Scores on a scale Standard Deviation 24.0	70.9 Scores on a scale Standard Deviation 20.9	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Total Cholesterol (Week 34)	0.03 mmol/L Standard Deviation 0.96	-0.10 mmol/L Standard Deviation 0.91	-0.09 mmol/L Standard Deviation 0.78	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Total Cholesterol (Week 87)	-0.21 mmol/L Standard Deviation 0.89	0.03 mmol/L Standard Deviation 0.96	-0.05 mmol/L Standard Deviation 0.94	-0.33 mmol/L Standard Deviation 1.08	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in HDL-cholesterol (Week 34)	-0.00 mmol/L Standard Deviation 0.37	0.02 mmol/L Standard Deviation 0.28	0.05 mmol/L Standard Deviation 0.30	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in HDL-cholesterol (Week 87)	0.06 mmol/L Standard Deviation 0.30	0.05 mmol/L Standard Deviation 0.32	0.09 mmol/L Standard Deviation 0.27	0.06 mmol/L Standard Deviation 0.34	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in LDL-cholesterol (Week 34)	0.02 mmol/L Standard Deviation 0.75	-0.18 mmol/L Standard Deviation 0.72	-0.13 mmol/L Standard Deviation 0.64	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in LDL-cholesterol (Week 87)	-0.30 mmol/L Standard Deviation 0.72	-0.06 mmol/L Standard Deviation 0.81	-0.15 mmol/L Standard Deviation 0.85	-0.36 mmol/L Standard Deviation 0.90	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Triglycerides (Week 34)	0.01 mmol/L Standard Deviation 0.65	0.13 mmol/L Standard Deviation 0.62	-0.02 mmol/L Standard Deviation 0.73	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Triglycerides (Week 87)	0.07 mmol/L Standard Deviation 0.48	0.03 mmol/L Standard Deviation 0.76	0.03 mmol/L Standard Deviation 0.56	-0.08 mmol/L Standard Deviation 0.73	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=116 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Hs-CRP (Week 34)	0.405 mg/L Standard Deviation 13.144	-1.604 mg/L Standard Deviation 13.254	-0.569 mg/L Standard Deviation 5.616	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Hs-CRP (Week 87)	-0.325 mg/L Standard Deviation 16.247	-1.445 mg/L Standard Deviation 3.791	-0.857 mg/L Standard Deviation 17.491	-1.257 mg/L Standard Deviation 12.497	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in IL-6 (Week 34)	3.48 pg/mL Standard Deviation 24.84	0.07 pg/mL Standard Deviation 4.01	0.18 pg/mL Standard Deviation 5.78	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in IL-6 (Week 87)	0.11 pg/mL Standard Deviation 3.30	0.52 pg/mL Standard Deviation 6.19	0.49 pg/mL Standard Deviation 5.12	1.19 pg/mL Standard Deviation 2.92	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Body Weight (Week 34)	0.6 Kg Standard Deviation 2.9	0.2 Kg Standard Deviation 4.0	1.3 Kg Standard Deviation 4.2	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Body Weight (Week 87)	1.2 Kg Standard Deviation 4.4	1.4 Kg Standard Deviation 4.8	0.4 Kg Standard Deviation 5.2	2.1 Kg Standard Deviation 7.0	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analysed = number of participants with available data.

Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=117 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Waist Circumference (Week 34)	0.82 cm Standard Deviation 4.50	-0.66 cm Standard Deviation 4.83	-0.00 cm Standard Deviation 4.52	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analysed = number of participants with available data.

Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Waist Circumference (Week 87)	1.35 cm Standard Deviation 5.62	0.53 cm Standard Deviation 5.17	-2.26 cm Standard Deviation 7.93	0.74 cm Standard Deviation 7.17	—

SECONDARY outcome

Timeframe: Weeks 0-35

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Number of Adverse Events (Weeks 0-35)	184 Events	426 Events	385 Events	—	—

SECONDARY outcome

Timeframe: Weeks 0-88

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- n=16 Participants Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Number of Adverse Events (Weeks 0-88)	395 Events	699 Events	384 Events	385 Events	49 Events

SECONDARY outcome

Timeframe: Weeks 0 to 35

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)	0 Participants	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Weeks 0 to 88

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- n=16 Participants Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 0 to 35

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Incidence of technical complaints were recorded from baseline (week 0) until week 35.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)	1 Technical complaints	14 Technical complaints	0 Technical complaints	—	—

SECONDARY outcome

Timeframe: Weeks 0 to 88

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Incidence of technical complaints were recorded from baseline (week 0) until week 88.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)	1 Technical complaints	6 Technical complaints	18 Technical complaints	7 Technical complaints	—

SECONDARY outcome

Timeframe: Week 0 and week 35

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \& Peripheral nervous sys. 7) Skin 8) Lymph node palpation

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 0) · Normal	55 Participants	111 Participants	108 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 0) · Abnormal, not clinically significant (NCS)	6 Participants	6 Participants	7 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 0) · Abnormal, clinically significant (CS)	0 Participants	2 Participants	5 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 35) · Normal	51 Participants	98 Participants	107 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 35) · Abnormal, not clinically significant (NCS)	5 Participants	4 Participants	9 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 35) · Abnormal, clinically significant (CS)	0 Participants	3 Participants	2 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Head, neck, eyes, nose (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 0) · Normal	61 Participants	118 Participants	119 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 0) · Abnormal, not clinically significant (NCS)	0 Participants	1 Participants	1 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 0) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 35) · Normal	56 Participants	103 Participants	117 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 35) · Abnormal, not clinically significant (NCS)	0 Participants	2 Participants	1 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 35) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Respiratory sys. (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 0) · Normal	56 Participants	112 Participants	116 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 0) · Abnormal, not clinically significant (NCS)	4 Participants	7 Participants	4 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 0) · Abnormal, clinically significant (CS)	1 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 35) · Normal	54 Participants	99 Participants	112 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 35) · Abnormal, not clinically significant (NCS)	1 Participants	6 Participants	6 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 35) · Abnormal, clinically significant (CS)	1 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Cardiovascular sys. (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 0) · Normal	59 Participants	113 Participants	119 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 0) · Abnormal, not clinically significant (NCS)	2 Participants	6 Participants	1 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 0) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 35) · Normal	53 Participants	98 Participants	116 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 35) · Abnormal, not clinically significant (NCS)	3 Participants	7 Participants	2 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 35) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Gastrointestinal sys. (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 0) · Normal	59 Participants	111 Participants	113 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 0) · Abnormal, not clinically significant (NCS)	2 Participants	6 Participants	5 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 0) · Abnormal, clinically significant (CS)	0 Participants	2 Participants	2 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 35) · Normal	54 Participants	96 Participants	111 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 35) · Abnormal, not clinically significant (NCS)	2 Participants	7 Participants	5 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 35) · Abnormal, clinically significant (CS)	0 Participants	2 Participants	2 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Musculoskeletal sys. (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 0) · Normal	59 Participants	113 Participants	117 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 0) · Abnormal, not clinically significant (NCS)	2 Participants	5 Participants	3 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 0) · Abnormal, clinically significant (CS)	0 Participants	1 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 35) · Normal	55 Participants	101 Participants	114 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 35) · Abnormal, not clinically significant (NCS)	1 Participants	4 Participants	4 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 35) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Central & Peripheral nervous sys (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 0) · Normal	51 Participants	100 Participants	109 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 0) · Abnormal, not clinically significant (NCS)	9 Participants	17 Participants	11 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 0) · Abnormal, clinically significant (CS)	1 Participants	2 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 35) · Normal	51 Participants	88 Participants	102 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 35) · Abnormal, not clinically significant (NCS)	5 Participants	15 Participants	13 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 35) · Abnormal, clinically significant (CS)	0 Participants	2 Participants	3 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Skin (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 0) · Normal	61 Participants	119 Participants	120 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 0) · Abnormal, not clinically significant (NCS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 0) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 0) · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 35) · Normal	56 Participants	105 Participants	118 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 35) · Abnormal, not clinically significant (NCS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 35) · Abnormal, clinically significant (CS)	0 Participants	0 Participants	0 Participants	—	—
Change in Physical Examination During Exposure to Trial Product (Week 35) Lymph node palpation (Week 35) · Missing	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 0 and week 88

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \& Peripheral nervous sys. 7) Skin 8) Lymph node palpation

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- n=16 Participants Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 0) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 88) · Normal	53 Participants	108 Participants	49 Participants	48 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 88) · Abnormal, NCS	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 88) · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 88) · Normal	52 Participants	107 Participants	45 Participants	47 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 0) · Normal	55 Participants	108 Participants	49 Participants	47 Participants	15 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 0) · Abnormal, NCS	6 Participants	7 Participants	2 Participants	3 Participants	1 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 0) · Abnormal, CS	0 Participants	5 Participants	1 Participants	1 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 88) · Normal	48 Participants	101 Participants	46 Participants	44 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 88) · Abnormal, NCS	6 Participants	7 Participants	2 Participants	1 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 88) · Abnormal, CS	0 Participants	1 Participants	1 Participants	3 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Head, neck, eyes, nose (Week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 0) · Normal	61 Participants	119 Participants	52 Participants	50 Participants	16 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 0) · Abnormal, NCS	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 0) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 88) · Normal	54 Participants	109 Participants	49 Participants	47 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 88) · Abnormal, NCS	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 88) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Respiratory sys. (Week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 0) · Normal	56 Participants	116 Participants	49 Participants	47 Participants	16 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 0) · Abnormal, NCS	4 Participants	4 Participants	3 Participants	4 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 0) · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 88) · Abnormal, NCS	1 Participants	2 Participants	4 Participants	1 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 88) · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Cardiovascular sys. (Week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 0) · Normal	59 Participants	119 Participants	49 Participants	49 Participants	15 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 0) · Abnormal, NCS	2 Participants	1 Participants	3 Participants	2 Participants	1 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 0) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 88) · Normal	52 Participants	109 Participants	47 Participants	48 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 88) · Abnormal, NCS	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 88) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Gastrointestinal sys. (Week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 0) · Normal	59 Participants	113 Participants	48 Participants	49 Participants	14 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 0) · Abnormal, NCS	2 Participants	5 Participants	2 Participants	2 Participants	2 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 0) · Abnormal, CS	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 88) · Normal	49 Participants	101 Participants	45 Participants	46 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 88) · Abnormal, NCS	4 Participants	7 Participants	3 Participants	2 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 88) · Abnormal, CS	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Musculoskeletal sys. (Week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 0) · Normal	59 Participants	117 Participants	51 Participants	48 Participants	14 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 0) · Abnormal, NCS	2 Participants	3 Participants	1 Participants	3 Participants	1 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 0) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 88) · Normal	53 Participants	106 Participants	49 Participants	45 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 88) · Abnormal, NCS	1 Participants	3 Participants	0 Participants	3 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 88) · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Central & Peripheral nervous sys. (week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 0) · Normal	51 Participants	109 Participants	48 Participants	41 Participants	11 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 0) · Abnormal, NCS	9 Participants	11 Participants	3 Participants	10 Participants	4 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 0) · Abnormal, CS	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 0) · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 88) · Normal	49 Participants	96 Participants	42 Participants	42 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 88) · Abnormal, NCS	3 Participants	8 Participants	6 Participants	5 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 88) · Abnormal, CS	2 Participants	5 Participants	1 Participants	1 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Skin (Week 88) · Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 0) · Normal	61 Participants	120 Participants	52 Participants	51 Participants	16 Participants
Change in Physical Examination During Exposure to Trial Product (Week 88) Lymph node palpation (week 0) · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week -3 and week 35

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=119 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=120 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week -3 · Normal	30 Participants	67 Participants	77 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week -3 · Abnormal, NCS	29 Participants	52 Participants	40 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week -3 · Abnormal, CS	2 Participants	0 Participants	3 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week -3 · Missing	0 Participants	0 Participants	0 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week 35 · Normal	29 Participants	65 Participants	77 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week 35 · Abnormal, NCS	26 Participants	42 Participants	34 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week 35 · Abnormal, CS	1 Participants	0 Participants	2 Participants	—	—
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) Week 35 · Missing	1 Participants	4 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Week -3 and week 88

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.

Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=120 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=52 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=51 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- n=16 Participants Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week -3 · Normal	30 Participants	77 Participants	26 Participants	34 Participants	7 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week -3 · Abnormal, NCS	29 Participants	40 Participants	26 Participants	17 Participants	9 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week -3 · Abnormal, CS	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week -3 · Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week 88 · Normal	34 Participants	74 Participants	29 Participants	35 Participants	0 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week 88 · Abnormal, NCS	18 Participants	34 Participants	18 Participants	12 Participants	0 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week 88 · Abnormal, CS	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Change in ECG Evaluation During Exposure to Trial Product (Week 88) Week 88 · Missing	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week -3, week 35

Population: Overall number of participants analyzed = number of participants with available data.

Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=107 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Diastolic Blood Pressure (Week 35)	-0.41 mm Hg Standard Deviation 7.75	-2.07 mm Hg Standard Deviation 8.73	-1.42 mm Hg Standard Deviation 8.98	—	—

SECONDARY outcome

Timeframe: Week -3, week 88

Population: Overall number of participants analyzed = number of participants with available data.

Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Diastolic Blood Pressure (Week 88)	-2.48 mm Hg Standard Deviation 7.77	-0.85 mm Hg Standard Deviation 9.21	-0.61 mm Hg Standard Deviation 8.71	-2.10 mm Hg Standard Deviation 9.50	—

SECONDARY outcome

Timeframe: Week -3, week 35

Population: Overall number of participants analyzed = number of participants with available data.

Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=107 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Systolic Blood Pressure (Week 35)	1.13 mm Hg Standard Deviation 11.35	-2.81 mm Hg Standard Deviation 13.33	-1.39 mm Hg Standard Deviation 12.89	—	—

SECONDARY outcome

Timeframe: Week -3, week 88

Population: Overall number of participants analyzed = number of participants with available data.

Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Systolic Blood Pressure (Week 88)	-1.30 mm Hg Standard Deviation 12.18	0.45 mm Hg Standard Deviation 13.01	-1.35 mm Hg Standard Deviation 13.07	-1.83 mm Hg Standard Deviation 11.63	—

SECONDARY outcome

Timeframe: Week -3, week 35

Population: Overall number of participants analyzed = number of participants with available data.

Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Pulse (Week 35)	0.54 beats/min Standard Deviation 9.43	2.61 beats/min Standard Deviation 9.74	1.02 beats/min Standard Deviation 10.20	—	—

SECONDARY outcome

Timeframe: Week -3, week 88

Population: Overall number of participants analyzed = number of participants with available data.

Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Pulse (Week 88)	0.78 beats/min Standard Deviation 11.70	-0.55 beats/min Standard Deviation 10.51	-0.55 beats/min Standard Deviation 10.32	0.08 beats/min Standard Deviation 8.75	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Haemoglobin (Week 34)	1.87 g/L Standard Deviation 10.25	-0.51 g/L Standard Deviation 8.80	0.64 g/L Standard Deviation 8.78	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Haemoglobin (Week 87)	2.93 g/L Standard Deviation 11.36	2.76 g/L Standard Deviation 9.54	-0.40 g/L Standard Deviation 9.22	0.86 g/L Standard Deviation 15.96	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Haematocrit (Week 34)	0.5 % of red blood cells Standard Deviation 3.3	-0.3 % of red blood cells Standard Deviation 2.9	0.1 % of red blood cells Standard Deviation 3.1	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Haematocrit (Week 87)	0.17 % of red blood cells Standard Deviation 3.44	0.21 % of red blood cells Standard Deviation 3.29	-0.59 % of red blood cells Standard Deviation 2.78	-0.48 % of red blood cells Standard Deviation 5.10	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Erythrocytes (Week 34)	0.09 cells/pL Standard Deviation 0.33	0.06 cells/pL Standard Deviation 0.29	0.08 cells/pL Standard Deviation 0.32	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Erythrocytes (Week 87)	0.09 cells/pL Standard Deviation 0.34	0.12 cells/pL Standard Deviation 0.35	0.01 cells/pL Standard Deviation 0.31	0.05 cells/pL Standard Deviation 0.54	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Mean Corpuscular Volume (MCV) (Week 34)	-0.6 fL Standard Deviation 3.3	-1.8 fL Standard Deviation 3.6	-1.5 fL Standard Deviation 3.0	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Mean Corpuscular Volume (MCV) (Week 87)	-1.39 fL Standard Deviation 4.27	-1.80 fL Standard Deviation 3.31	-1.31 fL Standard Deviation 3.63	-1.77 fL Standard Deviation 3.66	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)	0.1 mmol/L Standard Deviation 0.5	0.1 mmol/L Standard Deviation 0.6	0.1 mmol/L Standard Deviation 0.6	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)	0.36 mmol/L Standard Deviation 0.47	0.29 mmol/L Standard Deviation 0.61	0.23 mmol/L Standard Deviation 0.70	0.35 mmol/L Standard Deviation 0.52	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=115 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Thrombocytes (Week 34)	1.6 10^9 cells/L Standard Deviation 37.4	10.8 10^9 cells/L Standard Deviation 37.1	15.3 10^9 cells/L Standard Deviation 35.0	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=108 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=47 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Thrombocytes (Week 87)	-1.2 10^9 cells/L Standard Deviation 44.7	11.0 10^9 cells/L Standard Deviation 36.7	-0.9 10^9 cells/L Standard Deviation 31.3	6.6 10^9 cells/L Standard Deviation 53.4	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Leucocytes (Week 34)	0.22 10^9 cells/L Standard Deviation 1.57	-0.05 10^9 cells/L Standard Deviation 1.50	-0.32 10^9 cells/L Standard Deviation 1.75	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Leucocytes (Week 87)	0.29 10^9 cells/L Standard Deviation 1.93	-0.12 10^9 cells/L Standard Deviation 1.94	-0.14 10^9 cells/L Standard Deviation 1.44	-0.14 10^9 cells/L Standard Deviation 2.55	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Alanine Aminotransferase (ALT) (Week 34)	4.5 U/L Standard Deviation 24.7	-1.4 U/L Standard Deviation 11.9	-4.4 U/L Standard Deviation 17.9	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in ALT was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Alanine Aminotransferase (ALT) (Week 87)	-1.1 U/L Standard Deviation 13.1	-4.3 U/L Standard Deviation 16.9	0.6 U/L Standard Deviation 12.5	-3.0 U/L Standard Deviation 14.6	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Albumin (Week 34)	6.09 g/L Standard Deviation 3.56	-0.72 g/L Standard Deviation 2.81	-0.42 g/L Standard Deviation 3.06	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Albumin was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Albumin (Week 87)	-1.19 g/L Standard Deviation 3.15	-0.86 g/L Standard Deviation 3.12	-1.12 g/L Standard Deviation 3.52	-1.69 g/L Standard Deviation 3.01	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Alkaline Phosphatase (ALP) (Week 34)	1.8 U/L Standard Deviation 16.5	7.9 U/L Standard Deviation 24.3	5.8 U/L Standard Deviation 14.9	—	—

SECONDARY outcome

Timeframe: Week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Alkaline Phosphatase (AP) (Week 87)	8.1 U/L Standard Deviation 20.2	5.4 U/L Standard Deviation 16.0	3.3 U/L Standard Deviation 22.2	4.2 U/L Standard Deviation 18.0	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Aspartate Aminotransferase (AST) (Week 34)	1.96 U/L Standard Deviation 15.11	-0.80 U/L Standard Deviation 9.38	-2.00 U/L Standard Deviation 13.97	—	—

SECONDARY outcome

Timeframe: Week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Aspartate Aminotransferase (AST) (Week 87)	1.76 U/L Standard Deviation 24.346	-2.17 U/L Standard Deviation 13.98	-0.43 U/L Standard Deviation 5.94	-1.69 U/L Standard Deviation 12.75	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Bilirubin (Week 34)	-0.08 umol/L Standard Deviation 4.76	-0.38 umol/L Standard Deviation 4.10	-0.41 umol/L Standard Deviation 4.09	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=47 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Bilirubin (Week 87)	0.04 umol/L Standard Deviation 3.77	0.14 umol/L Standard Deviation 4.45	0.45 umol/L Standard Deviation 3.24	-0.33 umol/L Standard Deviation 4.52	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Calcium (Week 34)	0.00 mmol/L Standard Deviation 0.13	0.04 mmol/L Standard Deviation 0.14	0.03 mmol/L Standard Deviation 0.11	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Calcium was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Calcium (Week 87)	0.01 mmol/L Standard Deviation 0.12	0.03 mmol/L Standard Deviation 0.12	0.03 mmol/L Standard Deviation 0.11	0.01 mmol/L Standard Deviation 0.12	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Chloride (Week 34)	-1.1 mmol/L Standard Deviation 2.7	-0.6 mmol/L Standard Deviation 2.9	-0.3 mmol/L Standard Deviation 2.9	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Chloride was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Chloride (Week 87)	-1.8 mmol/L Standard Deviation 3.5	-1.0 mmol/L Standard Deviation 3.0	-1.1 mmol/L Standard Deviation 3.2	-0.6 mmol/L Standard Deviation 3.1	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Creatinine (Week 34)	0.9 umol/L Standard Deviation 9.4	-2.8 umol/L Standard Deviation 10.9	-2.9 umol/L Standard Deviation 10.6	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Creatinine was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Creatinine (Week 87)	-5.6 umol/L Standard Deviation 11.9	-2.5 umol/L Standard Deviation 11.7	-2.0 umol/L Standard Deviation 9.8	1.8 umol/L Standard Deviation 41.2	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Creatine Kinase (Week 34)	5.0 U/L Standard Deviation 136.6	10.9 U/L Standard Deviation 101.0	-23.5 U/L Standard Deviation 355.0	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Creatine Kinase (Week 87)	228.7 U/L Standard Deviation 1603.3	-9.4 U/L Standard Deviation 411.3	1.3 U/L Standard Deviation 89.3	30.5 U/L Standard Deviation 125.7	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Gamma-glutamyl Transferase (GGT) (Week 34)	9.3 U/L Standard Deviation 66.2	-5.8 U/L Standard Deviation 17.0	-4.2 U/L Standard Deviation 27.5	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in GGT was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Gamma-glutamyl Transferase (GGT) (Week 87)	19.4 U/L Standard Deviation 16.4	29.3 U/L Standard Deviation 39.3	25.9 U/L Standard Deviation 23.8	20.7 U/L Standard Deviation 13.9	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Phosphate (Inorganic) (Week 34)	-0.038 mmol/L Standard Deviation 0.183	0.155 mmol/L Standard Deviation 0.182	0.181 mmol/L Standard Deviation 0.202	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Phosphate (Inorganic)(Week 87)	0.100 mmol/L Standard Deviation 0.190	0.125 mmol/L Standard Deviation 0.193	0.076 mmol/L Standard Deviation 0.190	0.115 mmol/L Standard Deviation 0.219	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Potassium (Week 34)	0.02 mmol/L Standard Deviation 0.44	-0.06 mmol/L Standard Deviation 0.39	0.04 mmol/L Standard Deviation 9.42	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Potassium was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Potassium (Week 87)	-0.06 mmol/L Standard Deviation 0.45	0.00 mmol/L Standard Deviation 0.44	-0.00 mmol/L Standard Deviation 0.40	-0.03 mmol/L Standard Deviation 0.43	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=108 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=115 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Sodium (Week 34)	0.1 mmol/L Standard Deviation 2.4	0.1 mmol/L Standard Deviation 2.9	0.5 mmol/L Standard Deviation 2.7	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Sodium (Week 87)	-0.7 mmol/L Standard Deviation 3.35	0.0 mmol/L Standard Deviation 2.92	-0.3 mmol/L Standard Deviation 2.74	0.5 mmol/L Standard Deviation 2.76	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Total Protein (Week 34)	-0.26 g/L Standard Deviation 5.48	-0.97 g/L Standard Deviation 4.36	-0.83 g/L Standard Deviation 4.93	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Total Protein (Week 87)	-1.20 g/L Standard Deviation 5.17	-0.74 g/L Standard Deviation 4.88	-1.31 g/L Standard Deviation 4.91	-1.59 g/L Standard Deviation 4.37	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Urea (Week 34)	0.17 mmol/L Standard Deviation 1.27	-0.40 mmol/L Standard Deviation 1.16	-0.19 mmol/L Standard Deviation 1.24	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Urea (Week 87)	0.11 mmol/L Standard Deviation 1.40	-0.21 mmol/L Standard Deviation 1.28	-0.26 mmol/L Standard Deviation 1.35	-0.03 mmol/L Standard Deviation 2.46	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Uric Acid (Week 34)	-8.228 umol/L Standard Deviation 52.557	-12.61 umol/L Standard Deviation 50.534	-21.11 umol/L Standard Deviation 57.594	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Uric Acid (Week 87)	-25.22 umol/L Standard Deviation 59.042	-21.95 umol/L Standard Deviation 58.903	-18.02 umol/L Standard Deviation 59.716	-31.31 umol/L Standard Deviation 86.787	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=113 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=118 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)	-1.34 mL/min/1.73m^2 Standard Deviation 10.68	2.77 mL/min/1.73m^2 Standard Deviation 10.07	2.57 mL/min/1.73m^2 Standard Deviation 11.24	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=49 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)	5.36 mL/min/1.73m^2 Standard Deviation 12.67	2.38 mL/min/1.73m^2 Standard Deviation 12.28	1.44 mL/min/1.73m^2 Standard Deviation 10.52	1.67 mL/min/1.73m^2 Standard Deviation 15.77	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=117 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Fasting Plasma Glucose (Week 34)	0.01 mmol/L Standard Deviation 0.42	0.12 mmol/L Standard Deviation 0.65	0.00 mmol/L Standard Deviation 0.56	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=108 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Fasting Plasma Glucose (Week 87)	0.06 mmol/L Standard Deviation 0.46	0.13 mmol/L Standard Deviation 0.77	0.05 mmol/L Standard Deviation 0.68	0.04 mmol/L Standard Deviation 0.60	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=112 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=117 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Fasting Insulin (Week 34)	14.563 pmol/L Standard Deviation 45.217	27.580 pmol/L Standard Deviation 76.230	12.778 pmol/L Standard Deviation 53.703	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=48 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Fasting Insulin (Week 87)	12.2 pmol/L Standard Deviation 57.31	-3.7 pmol/L Standard Deviation 62.39	-6.5 pmol/L Standard Deviation 53.67	13.4 pmol/L Standard Deviation 54.40	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=108 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=113 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Steady State Beta Cell Function (%B) (Week 34)	27.10 Percentage of beta cell function Standard Deviation 105.45	36.26 Percentage of beta cell function Standard Deviation 290.00	54.90 Percentage of beta cell function Standard Deviation 173.14	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=105 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=46 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=46 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Steady State Beta Cell Function (%B) (Week 87)	21.72 Percentage of beta cell function Standard Deviation 154.22	-16.54 Percentage of beta cell function Standard Deviation 148.72	-7.34 Percentage of beta cell function Standard Deviation 97.62	34.54 Percentage of beta cell function Standard Deviation 161.01	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=109 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=114 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Insulin Resistance (IR %) (Week 34)	0.53 Percentage of insulin resistance Standard Deviation 1.76	1.26 Percentage of insulin resistance Standard Deviation 3.42	0.47 Percentage of insulin resistance Standard Deviation 2.32	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=106 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=46 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=47 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Insulin Resistance (IR %) (Week 87)	0.50 Percentage of insulin resistance Standard Deviation 2.17	-0.06 Percentage of insulin resistance Standard Deviation 3.14	-0.02 Percentage of insulin resistance Standard Deviation 1.99	0.52 Percentage of insulin resistance Standard Deviation 2.26	—

SECONDARY outcome

Timeframe: Week -3, week 34

Population: Overall number of participants analyzed = number of participants with available data.

Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=111 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=119 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)	0.04 Percentage of HbA1c Standard Deviation 0.37	0.09 Percentage of HbA1c Standard Deviation 0.26	0.09 Percentage of HbA1c Standard Deviation 0.31	—	—

SECONDARY outcome

Timeframe: week -3, week 87

Population: Overall number of participants analyzed = number of participants with available data.

Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin n=110 Participants Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan n=49 Participants Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin/Somapacitan n=48 Participants Participants who received Norditropin in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial.	Norditropin/- Participants who received Norditropin in the main period of the trial and discontinued after the main period of the study are included here.
Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)	0.09 Percentage of HbA1c Standard Deviation 0.26	0.11 Percentage of HbA1c Standard Deviation 0.37	0.10 Percentage of HbA1c Standard Deviation 0.28	0.07 Percentage of HbA1c Standard Deviation 0.27	—

Adverse Events

Placebo - Main Phase

Serious events: 5 serious events

Other events: 29 other events

Deaths: 1 deaths

Somapacitan - Main Phase

Serious events: 7 serious events

Other events: 53 other events

Deaths: 0 deaths

Norditropin - Main Phase

Serious events: 12 serious events

Other events: 55 other events

Deaths: 1 deaths

Somapacitan - Extension Phase

Serious events: 15 serious events

Other events: 85 other events

Deaths: 2 deaths

Norditropin- Extension Phase

Serious events: 3 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Main Phase n=61 participants at risk Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan - Main Phase n=120 participants at risk Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin - Main Phase n=119 participants at risk Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan - Extension Phase n=220 participants at risk The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).	Norditropin- Extension Phase n=52 participants at risk The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).
Gastrointestinal disorders Abdominal pain	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Endocrine disorders Adrenocortical insufficiency acute	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Appendicitis	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Surgical and medical procedures Arterial stent insertion	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Investigations Blood testosterone increased	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Cardiac disorders Cardiogenic shock	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Investigations Cholangiogram	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Surgical and medical procedures Cholecystectomy	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Renal and urinary disorders Chronic kidney disease	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Clostridium difficile infection	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Death	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Psychiatric disorders Delirium	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Dental cyst	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Nervous system disorders Depressed level of consciousness	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Endocrine disorders Diabetes insipidus	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Diarrhoea	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Injury, poisoning and procedural complications Drug dispensing error	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Investigations Electrocardiogram T wave abnormal	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Injury, poisoning and procedural complications Fall	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Fatigue	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.91% 2/220 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Gastroenteritis	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.7% 2/120 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Gastroenteritis viral	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Blood and lymphatic system disorders Haemoconcentration	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Nervous system disorders Headache	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Herpes simplex	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Vascular disorders Hypertension	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Metabolism and nutrition disorders Hyponatraemia	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Endocrine disorders Hypopituitarism	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Influenza	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Inguinal hernia	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Renal and urinary disorders Nephrolithiasis	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Non-cardiac chest pain	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Pancreatitis acute	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.9% 1/52 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Pneumonia	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.9% 1/52 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Pneumonia viral	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Pyrexia	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Endocrine disorders Secondary adrenocortical insufficiency	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Sepsis	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Stomatitis	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Surgical and medical procedures Umbilical hernia repair	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Urinary tract infection	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.9% 1/52 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Urosepsis	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.9% 1/52 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Cardiac disorders Ventricular extrasystoles	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Cardiac disorders Ventricular fibrillation	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Viral infection	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Vomiting	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.45% 1/220 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.

Other adverse events

Other adverse events
Measure	Placebo - Main Phase n=61 participants at risk Participants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan - Main Phase n=120 participants at risk Participants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Norditropin - Main Phase n=119 participants at risk Participants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.	Somapacitan - Extension Phase n=220 participants at risk The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).	Norditropin- Extension Phase n=52 participants at risk The extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®).
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	6.7% 8/120 • Number of events 8 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	9.2% 11/119 • Number of events 11 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	3.2% 7/220 • Number of events 8 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 4 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Musculoskeletal and connective tissue disorders Back pain	3.3% 2/61 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	9.2% 11/120 • Number of events 11 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	3.4% 4/119 • Number of events 4 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.3% 5/220 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Diarrhoea	8.2% 5/61 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	3.3% 4/120 • Number of events 5 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	4.2% 5/119 • Number of events 5 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	6.4% 14/220 • Number of events 21 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Fatigue	3.3% 2/61 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.5% 3/120 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.9% 7/119 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	4.1% 9/220 • Number of events 11 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Nervous system disorders Headache	16.4% 10/61 • Number of events 15 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	8.3% 10/120 • Number of events 45 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	9.2% 11/119 • Number of events 50 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	11.4% 25/220 • Number of events 48 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	11.5% 6/52 • Number of events 23 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Vascular disorders Hypertension	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	3.3% 4/120 • Number of events 4 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	3.4% 4/119 • Number of events 4 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.4% 3/220 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Injection site bruising	3.3% 2/61 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.0% 6/119 • Number of events 6 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Musculoskeletal and connective tissue disorders Myalgia	4.9% 3/61 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.5% 3/119 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.3% 5/220 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Nasopharyngitis	14.8% 9/61 • Number of events 12 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	19.2% 23/120 • Number of events 29 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	16.8% 20/119 • Number of events 25 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	15.0% 33/220 • Number of events 41 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	11.5% 6/52 • Number of events 8 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Gastrointestinal disorders Nausea	1.6% 1/61 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.7% 2/120 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.0% 6/119 • Number of events 8 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.3% 5/220 • Number of events 14 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/52 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
General disorders Oedema peripheral	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	4.2% 5/120 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.0% 6/119 • Number of events 8 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	3.2% 7/220 • Number of events 17 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	1.9% 1/52 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Skin and subcutaneous tissue disorders Rash	3.3% 2/61 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.5% 3/120 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	2.5% 3/119 • Number of events 4 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.91% 2/220 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 4 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Tooth abscess	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.83% 1/120 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/119 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.91% 2/220 • Number of events 2 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Infections and infestations Upper respiratory tract infection	11.5% 7/61 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.0% 6/120 • Number of events 7 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	7.6% 9/119 • Number of events 10 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	7.7% 17/220 • Number of events 18 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 6 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.
Eye disorders Visual impairment	0.00% 0/61 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/120 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.84% 1/119 • Number of events 1 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	0.00% 0/220 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.	5.8% 3/52 • Number of events 3 • Weeks 0-88 All presented AEs are TEAEs. A treatment-emergent AE (TEAE) was defined as an event with onset after first study medicine administration. The results are based on the safety analysis set which included all randomised participants who received at least one dose of trial product.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

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