Trial Outcomes & Findings for A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (NCT NCT03878446)

NCT ID: NCT03878446

Last Updated: 2025-12-23

Results Overview

Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline (week 0); week 26
• Results posted on: 2025-12-23

Participant Flow

The trial was conducted at 38 sites in 12 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Austria (2/1), France (2/2), Hungary (1/1), India (3/3), Israel (1/1), Italy (2/2), Japan (10/10), Latvia (1/1), Russia (6/6), Thailand (2/1), Ukraine (2/2) and United States (6/5).

Participants were randomized (1:1:1:1:1 ratio) to receive either once-weekly Somapacitan or daily Norditropin treatment during the main phase (26-week) and extension phase I (26-week). Followed by 208-week additional long-term safety extension phase (extension II) and a 30-day follow-up period. Results in this summary are reported based on main phase and extension phase I. The extension phase II is still ongoing and results will be posted after one year of study completion date.

Participant milestones

Measure	Norditropin 0.035 mg/kg/Day Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Overall Study STARTED	12	13	12	13	12
Overall Study Safety Analysis Set (SAS)	12	13	12	13	12
Overall Study Full Analysis Set (FAS)	12	13	12	13	12
Overall Study Per Protocol Analysis Set	11	13	12	13	12
Overall Study COMPLETED	11	13	12	13	12
Overall Study NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Measure	Norditropin 0.035 mg/kg/Day Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Overall Study Withdrawn by parent or guardian	1	0	0	0	0

Baseline Characteristics

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Baseline characteristics by cohort

Measure	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Total n=62 Participants Total of all reporting groups	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).
Age, Continuous	5.92 years STANDARD_DEVIATION 2.44 • n=4 Participants	6.13 years STANDARD_DEVIATION 2.41 • n=219 Participants	6.17 years STANDARD_DEVIATION 2.21 • n=219 Participants	6.00 years STANDARD_DEVIATION 2.46 • n=880 Participants	6.10 years STANDARD_DEVIATION 2.39 • n=6 Participants	6.29 years STANDARD_DEVIATION 2.84 • n=68 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	4 Participants n=219 Participants	4 Participants n=219 Participants	4 Participants n=880 Participants	22 Participants n=6 Participants	6 Participants n=68 Participants
Sex: Female, Male Male	9 Participants n=4 Participants	8 Participants n=219 Participants	9 Participants n=219 Participants	8 Participants n=880 Participants	40 Participants n=6 Participants	6 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants	2 Participants n=6 Participants	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=4 Participants	8 Participants n=219 Participants	12 Participants n=219 Participants	11 Participants n=880 Participants	54 Participants n=6 Participants	12 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	4 Participants n=219 Participants	1 Participants n=219 Participants	1 Participants n=880 Participants	6 Participants n=6 Participants	0 Participants n=68 Participants
Race/Ethnicity, Customized White	8 Participants n=4 Participants	4 Participants n=219 Participants	7 Participants n=219 Participants	6 Participants n=880 Participants	34 Participants n=6 Participants	9 Participants n=68 Participants
Race/Ethnicity, Customized Asian	5 Participants n=4 Participants	6 Participants n=219 Participants	4 Participants n=219 Participants	6 Participants n=880 Participants	24 Participants n=6 Participants	3 Participants n=68 Participants
Race/Ethnicity, Customized Other	0 Participants n=4 Participants	0 Participants n=219 Participants	1 Participants n=219 Participants	0 Participants n=880 Participants	1 Participants n=6 Participants	0 Participants n=68 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=4 Participants	2 Participants n=219 Participants	1 Participants n=219 Participants	0 Participants n=880 Participants	3 Participants n=6 Participants	0 Participants n=68 Participants

PRIMARY outcome

Timeframe: Baseline (week 0); week 26

Population: Full analysis set (FAS) included all randomized participants exposed to the trial product.

Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Height Velocity	10.5 centimeter per year (cm/year) Standard Deviation 2.0	11.9 centimeter per year (cm/year) Standard Deviation 2.4	8.9 centimeter per year (cm/year) Standard Deviation 1.8	11.1 centimeter per year (cm/year) Standard Deviation 2.6	11.2 centimeter per year (cm/year) Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline (week 0); week 52

Population: Safety anslyis set (SAS) included all randomized participants exposed to the trial product. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in ratio of bone age (years) versus chronological age (years) from baseline (week 0) to week 52 is presented. X-rays of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. X-ray images were sent to a central imaging laboratory for evaluation. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 52 or last trial contact, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=11 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=11 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Ratio of Bone Age Versus Chronological Age	-0.02 ratio (bone age/chronological age) Standard Deviation 0.13	0.07 ratio (bone age/chronological age) Standard Deviation 0.16	0.07 ratio (bone age/chronological age) Standard Deviation 0.08	0.03 ratio (bone age/chronological age) Standard Deviation 0.12	-0.00 ratio (bone age/chronological age) Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: FAS included all randomized participants exposed to the trial product.

Change in HSDS from baseline (week 0) to week 26 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. HSDS = [(height/population median)^skewness - 1]/(skewness * population standard deviation) where skewness, median and standard deviation is given by a reference growth table for the corresponding chronological age. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Height Standard Deviation Score (HSDS)	0.61 score on a scale Standard Deviation 0.19	0.73 score on a scale Standard Deviation 0.30	0.41 score on a scale Standard Deviation 0.20	0.66 score on a scale Standard Deviation 0.29	0.66 score on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: FAS included all randomized participants exposed to the trial product.

Change in HVSDS from baseline (week 0) to week 26 is presented. HVSDS was derived using Prader standards. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HVSDS indicated that HVSDS was better than baseline HVSDS. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Height Velocity Standard Deviation Score (HVSDS)	6.37 score on a scale Standard Deviation 3.05	7.86 score on a scale Standard Deviation 1.88	4.03 score on a scale Standard Deviation 2.68	6.77 score on a scale Standard Deviation 3.35	7.24 score on a scale Standard Deviation 3.80

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: Safety analysis set (SAS) included all randomized participants exposed to trial product.

Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Fasting Plasma Glucose	0.382 millimoles per liter (mmol/L) Standard Deviation 0.500	0.192 millimoles per liter (mmol/L) Standard Deviation 0.415	0.167 millimoles per liter (mmol/L) Standard Deviation 0.485	0.200 millimoles per liter (mmol/L) Standard Deviation 0.912	0.275 millimoles per liter (mmol/L) Standard Deviation 0.693

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: SAS included all randomized participants exposed to trial product. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in HOMA-B from baseline (week 0) to week 26 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). HOMA-beta score ranges from minus infinity to infinity (no limits). Higher score means better beta-cell function for HOMA-beta. Negative change from baseline (week 0) in HOMA-B indicated a worse outcome. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=11 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B)	6.12 HOMA-B index Standard Deviation 99.55	63.35 HOMA-B index Standard Deviation 46.01	24.53 HOMA-B index Standard Deviation 49.59	0.75 HOMA-B index Standard Deviation 65.08	51.83 HOMA-B index Standard Deviation 88.89

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: SAS included all randomized participants exposed to trial product.

Change in HOMA-IR from baseline (week 0) to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a participant's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered insulin sensitive, 0.5-1.4: considered healthy, above 1.8: considered early insulin resistance; above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	0.85 HOMA-IR index Standard Deviation 0.82	1.17 HOMA-IR index Standard Deviation 0.88	0.40 HOMA-IR index Standard Deviation 0.48	0.57 HOMA-IR index Standard Deviation 3.07	1.50 HOMA-IR index Standard Deviation 2.10

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: SAS included all randomized participants exposed to trial product. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=11 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Glycated Haemoglobin (HbA1c)	-0.10 Percentage of HbA1c Standard Deviation 0.39	0.03 Percentage of HbA1c Standard Deviation 0.20	0.07 Percentage of HbA1c Standard Deviation 0.15	0.12 Percentage of HbA1c Standard Deviation 0.25	0.05 Percentage of HbA1c Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: FAS included all randomized participants exposed to the trial product.

Change in IGF-I SDS from baseline (week 0) to week 26 is presented. IGF-I SDS was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. Positive value in change from baseline in IGF-I SDS indicated that IGF-I SDS was higher than baseline IGF-I SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)	1.59 score on a scale Standard Deviation 0.67	2.13 score on a scale Standard Deviation 1.07	1.48 score on a scale Standard Deviation 0.90	1.93 score on a scale Standard Deviation 1.07	3.03 score on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline (week 0); week 26

Population: FAS included all randomized participants exposed to the trial product.

Change in IGFBP-3 SDS from baseline (week 0) to week 26 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. Positive value in change from baseline in IGFBP-3 SDS indicated that IGFBP-3 SDS was higher than baseline IGFBP-3 SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first.

Outcome measures

Measure	Norditropin 0.035 mg/kg/Day n=12 Participants Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin 0.067 mg/kg/Day n=13 Participants Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.16 mg/kg/Week n=12 Participants Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.20 mg/kg/Week n=13 Participants Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan 0.24 mg/kg/Week n=12 Participants Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS	0.81 score on a scale Standard Deviation 0.64	1.06 score on a scale Standard Deviation 0.66	0.77 score on a scale Standard Deviation 0.68	1.01 score on a scale Standard Deviation 0.80	1.40 score on a scale Standard Deviation 0.88

Adverse Events

Norditropin (0.035mg/kg/Day)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Norditropin (0.067mg/kg/Day)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Somapacitan (0.16mg/kg/Week)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Somapacitan (0.20mg/kg/Week)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Somapacitan (0.24mg/kg/Week)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Norditropin (0.035mg/kg/Day) n=12 participants at risk Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin (0.067mg/kg/Day) n=13 participants at risk Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan (0.16mg/kg/Week) n=12 participants at risk Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan (0.20mg/kg/Week) n=13 participants at risk Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan (0.24mg/kg/Week) n=12 participants at risk Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Gastrointestinal disorders Inguinal hernia	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.

Other adverse events

Measure	Norditropin (0.035mg/kg/Day) n=12 participants at risk Participants received 0.035 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Norditropin (0.067mg/kg/Day) n=13 participants at risk Participants received 0.067 mg/kg/day subcutaneous injection of norditropin daily during the main phase (26-week) and extension phase I (26-week).	Somapacitan (0.16mg/kg/Week) n=12 participants at risk Participants received 0.16 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan (0.20mg/kg/Week) n=13 participants at risk Participants received 0.20 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).	Somapacitan (0.24mg/kg/Week) n=12 participants at risk Participants received 0.24 mg/kg/week subcutaneous injection of somapacitan once weekly during the main phase (26-week) and extension phase I (26-week).
Psychiatric disorders Anxiety	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	15.4% 2/13 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Psychiatric disorders Behaviour disorder	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Bronchitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 3 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	15.4% 2/13 • Number of events 4 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Conjunctivitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Constipation	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 3 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Dental caries	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Ear infection	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Psychiatric disorders Enuresis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Nervous system disorders Headache	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 3 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Influenza	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
General disorders Influenza like illness	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Eye disorders Amblyopia	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Blood and lymphatic system disorders Iron deficiency anaemia	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	25.0% 3/12 • Number of events 6 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	15.4% 2/13 • Number of events 4 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	25.0% 3/12 • Number of events 5 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Otitis externa	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Otitis media	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Pharyngitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Pneumonia	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Investigations Protein urine present	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
General disorders Pyrexia	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 4 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Respiratory tract infection viral	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Rhinitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	16.7% 2/12 • Number of events 6 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Stomatitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	15.4% 2/13 • Number of events 4 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	15.4% 2/13 • Number of events 3 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Varicella	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Viral infection	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Gastrointestinal disorders Vomiting	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	16.7% 2/12 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 3 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Immune system disorders Allergy to arthropod bite	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Eye disorders Astigmatism	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	16.7% 2/12 • Number of events 2 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Gastroenteritis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Musculoskeletal and connective tissue disorders Growing pains	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Lipoatrophy	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Oral herpes	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Otitis media acute	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Vascular disorders Pallor	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	7.7% 1/13 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	8.3% 1/12 • Number of events 1 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/13 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.	0.00% 0/12 • From Baseline (Week 0) to Week 52 All presented adverse events are treatment emergent adverse events (TEAEs) defined as an event that had onset after the first administration of trial product and up until 14 days after last trial drug administration for withdrawn participants, and with an onset after the first administration of trial product and up week 52. Results are based on the SAS which included all randomized participants exposed to trial product.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
• Publication restrictions are in place

Restriction type: OTHER