Trial Outcomes & Findings for Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome (NCT NCT02527200)

NCT ID: NCT02527200

Last Updated: 2023-07-06

Results Overview

Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 56 participants
• Primary outcome timeframe: Week 0, Week 16
• Results posted on: 2023-07-06

Participant Flow

The trial was conducted at 20 sites in 8 countries as follows: Australia (2), Canada (1), France (7), Italy (2), Netherlands (1), New Zealand (1), Turkey (3), and the United States (3).

Trial has part A & B, participants entered sequentially into part A & B, and were randomised 2:1 (liraglutide/placebo). Part A conducted in adolescents (≥12-<18 years [yrs], Tanner stage 2-5) with Prader-Willi Syndrome (PWS) and obesity; Part B in children (≥6-˂12 yrs, Tanner stage below 2 with PWS and obesity. On part A 16-week double-blind period completion, data monitoring committee reviewed PK data to un-blind part A safety data then recommended randomisation (liraglutide/placebo) in part B.

Participant milestones

Measure	Part A: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Overall Study STARTED	20	12	17	7
Overall Study Safety Analysis Set (SAS)	20	12	17	7
Overall Study Full Analysis Set (FAS)	19	12	17	7
Overall Study COMPLETED	17	9	15	7
Overall Study NOT COMPLETED	3	3	2	0

Reasons for withdrawal

Measure	Part A: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Overall Study Withdrawal by Subject	3	2	1	0
Overall Study Unclassified	0	1	0	0
Overall Study Lost to Follow-up	0	0	1	0

Baseline Characteristics

Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome

Baseline characteristics by cohort

Measure	Part A: Liraglutide n=19 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Total n=55 Participants Total of all reporting groups
Age, Customized 6 - <12 years	0 Participants n=5 Participants	0 Participants n=7 Participants	17 Participants n=5 Participants	7 Participants n=4 Participants	24 Participants n=21 Participants
Age, Customized 12 - <18 years	19 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	31 Participants n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	2 Participants n=4 Participants	28 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	6 Participants n=4 Participants	47 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	17 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 0, Week 16

Population: Full analysis set (FAS) which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed" = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks	-0.50 SDS score Standard Deviation 0.65	-0.48 SDS score Standard Deviation 0.39	-0.18 SDS score Standard Deviation 0.21	-0.18 SDS score Standard Deviation 0.23	-0.33 SDS score Standard Deviation 0.49	-0.29 SDS score Standard Deviation 0.32

PRIMARY outcome

Timeframe: Week 0, Week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks	-0.79 SDS score Standard Deviation 1.21	-0.71 SDS score Standard Deviation 0.68	-0.27 SDS score Standard Deviation 0.37	-0.13 SDS score Standard Deviation 0.25	-0.50 SDS score Standard Deviation 0.88	-0.36 SDS score Standard Deviation 0.53

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 No	62.5 Percentage of participants	42.9 Percentage of participants	72.2 Percentage of participants	91.7 Percentage of participants	67.6 Percentage of participants	73.7 Percentage of participants
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 Yes	37.5 Percentage of participants	57.1 Percentage of participants	27.8 Percentage of participants	8.3 Percentage of participants	32.4 Percentage of participants	26.3 Percentage of participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 No	64.3 Percentage of participants	57.1 Percentage of participants	70.6 Percentage of participants	81.8 Percentage of participants	67.7 Percentage of participants	72.2 Percentage of participants
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 Yes	35.7 Percentage of participants	42.9 Percentage of participants	29.4 Percentage of participants	18.2 Percentage of participants	32.3 Percentage of participants	27.8 Percentage of participants

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 Yes	6.3 Percentage of participants	14.3 Percentage of participants	0 Percentage of participants	0 Percentage of participants	2.9 Percentage of participants	5.3 Percentage of participants
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 No	93.8 Percentage of participants	85.7 Percentage of participants	100 Percentage of participants	100 Percentage of participants	97.1 Percentage of participants	94.7 Percentage of participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 Yes	14.3 Percentage of participants	28.6 Percentage of participants	11.8 Percentage of participants	0 Percentage of participants	12.9 Percentage of participants	11.1 Percentage of participants
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 No	85.7 Percentage of participants	71.4 Percentage of participants	88.2 Percentage of participants	100 Percentage of participants	87.1 Percentage of participants	88.9 Percentage of participants

SECONDARY outcome

Timeframe: At week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Percentage of Participants With no Increase in BMI SDS at Week 16 Yes	87.5 Percentage of participants	100 Percentage of participants	66.7 Percentage of participants	75.0 Percentage of participants	76.5 Percentage of participants	84.2 Percentage of participants
Percentage of Participants With no Increase in BMI SDS at Week 16 No	12.5 Percentage of participants	0 Percentage of participants	33.3 Percentage of participants	25.0 Percentage of participants	23.5 Percentage of participants	15.8 Percentage of participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Percentage of Participants With no Increase in BMI SDS at Week 52 Yes	78.6 Percentage of participants	100 Percentage of participants	70.6 Percentage of participants	72.7 Percentage of participants	73.3 Percentage of participants	81.3 Percentage of participants
Percentage of Participants With no Increase in BMI SDS at Week 52 No	21.4 Percentage of participants	0 Percentage of participants	29.4 Percentage of participants	27.3 Percentage of participants	26.7 Percentage of participants	18.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body mass index (BMI) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in BMI From Baseline at Week 16	-1.1 kilogram per meter square (kg/m^2) Standard Deviation 1.5	-1.5 kilogram per meter square (kg/m^2) Standard Deviation 1.7	-0.9 kilogram per meter square (kg/m^2) Standard Deviation 1.4	-0.8 kilogram per meter square (kg/m^2) Standard Deviation 1.6	-1.0 kilogram per meter square (kg/m^2) Standard Deviation 1.4	-1.1 kilogram per meter square (kg/m^2) Standard Deviation 1.6

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body mass index (BMI) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in BMI From Baseline at Week 52	-0.6 kg/m^2 Standard Deviation 3.3	-0.7 kg/m^2 Standard Deviation 2.7	0.8 kg/m^2 Standard Deviation 2.2	-0.1 kg/m^2 Standard Deviation 2.1	-0.7 kg/m^2 Standard Deviation 2.7	-0.4 kg/m^2 Standard Deviation 2.3

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body weight (kg) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16	-0.6 (kilogram (kg)) Standard Deviation 2.2	-1.0 (kilogram (kg)) Standard Deviation 2.7	-1.7 (kilogram (kg)) Standard Deviation 3.6	-1.1 (kilogram (kg)) Standard Deviation 5.0	-1.2 (kilogram (kg)) Standard Deviation 3.0	-1.0 (kilogram (kg)) Standard Deviation 4.2

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. (kilogram (kg))

Change in body weight (kg) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Weight (kg) From Baseline at Week 52	3.0 kilogram Standard Deviation 6.6	2.8 kilogram Standard Deviation 5.2	-0.4 kilogram Standard Deviation 6.3	1.9 kilogram Standard Deviation 6.0	1.1 kilogram Standard Deviation 6.5	2.3 kilogram Standard Deviation 5.6

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body weight (lb) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Weight (Pounds (lb)) From Baseline at Week 16	-1.4 pounds (lb) Standard Deviation 4.8	-2.1 pounds (lb) Standard Deviation 5.9	-3.7 pounds (lb) Standard Deviation 7.8	-2.4 pounds (lb) Standard Deviation 11.0	-2.6 pounds (lb) Standard Deviation 6.6	-2.3 pounds (lb) Standard Deviation 9.2

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body weight (lb) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Weight (lb) From Baseline at Week 52	6.7 pounds Standard Deviation 14.4	6.2 pounds Standard Deviation 11.5	-0.9 pounds Standard Deviation 13.9	4.3 pounds Standard Deviation 13.2	2.5 pounds Standard Deviation 14.4	5.0 pounds Standard Deviation 12.3

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body weight (%) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Weight (Percentage [%]) From Baseline at Week 16	-1.1 Percent change in body weight Standard Deviation 4.1	-2.2 Percent change in body weight Standard Deviation 5.5	-1.7 Percent change in body weight Standard Deviation 3.8	-0.7 Percent change in body weight Standard Deviation 3.7	-1.4 Percent change in body weight Standard Deviation 3.9	-1.2 Percent change in body weight Standard Deviation 4.3

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in body weight (%) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Body Weight (%) From Baseline at Week 52	6.3 Percent change in body weight Standard Deviation 12.1	4.9 Percent change in body weight Standard Deviation 8.6	-0.4 Percent change in body weight Standard Deviation 6.5	2.3 Percent change in body weight Standard Deviation 5.7	2.6 Percent change in body weight Standard Deviation 9.9	3.3 Percent change in body weight Standard Deviation 6.9

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in waist circumference from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=33 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Waist Circumference From Baseline at Week 16	-0.73 centimeters (cm) Standard Deviation 6.14	-1.04 centimeters (cm) Standard Deviation 4.53	-2.50 centimeters (cm) Standard Deviation 4.52	-2.44 centimeters (cm) Standard Deviation 7.84	-1.70 centimeters (cm) Standard Deviation 5.31	-1.92 centimeters (cm) Standard Deviation 6.70

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in waist circumference from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Waist Circumference From Baseline at Week 52	0.45 centimeter Standard Deviation 8.05	0.97 centimeter Standard Deviation 5.99	-2.98 centimeter Standard Deviation 8.68	-3.48 centimeter Standard Deviation 7.32	-1.49 centimeter Standard Deviation 8.45	-2.09 centimeter Standard Deviation 7.06

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in waist-to-hip circumference ratio from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=33 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Waist-to-hip Circumference Ratio From Baseline at Week 16	0.00 Waist-to-hip circumference ratio Standard Deviation 0.06	0.01 Waist-to-hip circumference ratio Standard Deviation 0.04	-0.01 Waist-to-hip circumference ratio Standard Deviation 0.04	-0.02 Waist-to-hip circumference ratio Standard Deviation 0.06	-0.01 Waist-to-hip circumference ratio Standard Deviation 0.05	-0.01 Waist-to-hip circumference ratio Standard Deviation 0.05

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in waist-to-hip circumference ratio from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Waist-to-hip Circumference Ratio From Baseline at Week 52	-0.02 waist-to-hip circumference ratio Standard Deviation 0.05	-0.01 waist-to-hip circumference ratio Standard Deviation 0.07	-0.01 waist-to-hip circumference ratio Standard Deviation 0.06	-0.04 waist-to-hip circumference ratio Standard Deviation 0.06	-0.02 waist-to-hip circumference ratio Standard Deviation 0.06	-0.03 waist-to-hip circumference ratio Standard Deviation 0.06

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=19 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=36 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 Hyperphagia behaviour score	-1.2 Score on a scale Standard Deviation 3.83	-2.6 Score on a scale Standard Deviation 2.07	-0.8 Score on a scale Standard Deviation 2.01	-1.7 Score on a scale Standard Deviation 4.14	-1.0 Score on a scale Standard Deviation 2.97	-2.0 Score on a scale Standard Deviation 3.48
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 Hyperphagia drive score	-1.8 Score on a scale Standard Deviation 2.97	-2.0 Score on a scale Standard Deviation 2.89	-0.9 Score on a scale Standard Deviation 2.80	-0.9 Score on a scale Standard Deviation 2.61	-1.3 Score on a scale Standard Deviation 2.87	-1.3 Score on a scale Standard Deviation 2.69
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 Hyperphagia total score	-3.1 Score on a scale Standard Deviation 7.28	-4.4 Score on a scale Standard Deviation 5.65	-2.4 Score on a scale Standard Deviation 5.55	-2.9 Score on a scale Standard Deviation 5.79	-2.7 Score on a scale Standard Deviation 6.34	-3.5 Score on a scale Standard Deviation 5.63
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 Hyperphagia severity score	-0.1 Score on a scale Standard Deviation 1.65	0.1 Score on a scale Standard Deviation 1.46	-0.6 Score on a scale Standard Deviation 1.54	-0.3 Score on a scale Standard Deviation 2.46	-0.4 Score on a scale Standard Deviation 1.59	-0.2 Score on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=32 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 Hyperphagia behaviour score	-0.7 Score on a scale Standard Deviation 4.63	-2.6 Score on a scale Standard Deviation 3.65	-0.9 Score on a scale Standard Deviation 3.20	-0.6 Score on a scale Standard Deviation 2.62	-0.8 Score on a scale Standard Deviation 3.82	-1.3 Score on a scale Standard Deviation 3.00
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 Hyperphagia drive score	-1.1 Score on a scale Standard Deviation 3.99	-1.4 Score on a scale Standard Deviation 4.45	-2.2 Score on a scale Standard Deviation 2.90	-0.5 Score on a scale Standard Deviation 2.42	-1.7 Score on a scale Standard Deviation 3.41	-0.8 Score on a scale Standard Deviation 3.06
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 Hyperphagia severity score	-0.4 Score on a scale Standard Deviation 2.73	-1.4 Score on a scale Standard Deviation 1.82	-1.3 Score on a scale Standard Deviation 1.81	-0.9 Score on a scale Standard Deviation 2.51	-0.9 Score on a scale Standard Deviation 2.27	-1.1 Score on a scale Standard Deviation 2.26
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 Hyperphagia total score	-2.1 Score on a scale Standard Deviation 10.11	-5.4 Score on a scale Standard Deviation 8.32	-4.4 Score on a scale Standard Deviation 6.57	-2.1 Score on a scale Standard Deviation 6.11	-3.4 Score on a scale Standard Deviation 8.23	-3.1 Score on a scale Standard Deviation 6.77

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in hsCRP from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16	-2.79 Milligram per liter (mg/L) Standard Deviation 8.03	1.87 Milligram per liter (mg/L) Standard Deviation 2.12	0.79 Milligram per liter (mg/L) Standard Deviation 2.58	-0.57 Milligram per liter (mg/L) Standard Deviation 6.61	-0.61 Milligram per liter (mg/L) Standard Deviation 5.57	0.24 Milligram per liter (mg/L) Standard Deviation 5.57

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in hsCRP from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52	-2.42 mg/L Standard Deviation 9.19	-0.37 mg/L Standard Deviation 0.84	0.25 mg/L Standard Deviation 2.55	0.14 mg/L Standard Deviation 3.67	-0.89 mg/L Standard Deviation 6.31	-0.03 mg/L Standard Deviation 2.99

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Total Cholesterol From Baseline at Week 16	1.02 Ratio of total cholesterol Standard Deviation 0.11	0.97 Ratio of total cholesterol Standard Deviation 0.10	0.99 Ratio of total cholesterol Standard Deviation 0.10	1.06 Ratio of total cholesterol Standard Deviation 0.14	1.00 Ratio of total cholesterol Standard Deviation 0.10	1.03 Ratio of total cholesterol Standard Deviation 0.14

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Total Cholesterol From Baseline at Week 52	1.01 Ratio of total cholesterol Standard Deviation 0.12	1.07 Ratio of total cholesterol Standard Deviation 0.07	1.00 Ratio of total cholesterol Standard Deviation 0.18	1.06 Ratio of total cholesterol Standard Deviation 0.15	1.01 Ratio of total cholesterol Standard Deviation 0.15	1.06 Ratio of total cholesterol Standard Deviation 0.13

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16	1.04 Ratio of LDL-cholesterol Standard Deviation 0.17	0.96 Ratio of LDL-cholesterol Standard Deviation 0.14	1.01 Ratio of LDL-cholesterol Standard Deviation 0.15	1.13 Ratio of LDL-cholesterol Standard Deviation 0.19	1.02 Ratio of LDL-cholesterol Standard Deviation 0.16	1.07 Ratio of LDL-cholesterol Standard Deviation 0.19

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52	0.99 Ratio of LDL-cholesterol Standard Deviation 0.19	1.06 Ratio of LDL-cholesterol Standard Deviation 0.10	1.02 Ratio of LDL-cholesterol Standard Deviation 0.22	1.12 Ratio of LDL-cholesterol Standard Deviation 0.23	1.01 Ratio of LDL-cholesterol Standard Deviation 0.20	1.10 Ratio of LDL-cholesterol Standard Deviation 0.19

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16	1.01 Ratio of HDL-cholesterol Standard Deviation 0.14	1.12 Ratio of HDL-cholesterol Standard Deviation 0.13	0.96 Ratio of HDL-cholesterol Standard Deviation 0.14	1.00 Ratio of HDL-cholesterol Standard Deviation 0.20	0.98 Ratio of HDL-cholesterol Standard Deviation 0.14	1.04 Ratio of HDL-cholesterol Standard Deviation 0.19

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52	1.06 Ratio of HDL-cholesterol Standard Deviation 0.16	1.08 Ratio of HDL-cholesterol Standard Deviation 0.12	0.99 Ratio of HDL-cholesterol Standard Deviation 0.19	1.02 Ratio of HDL-cholesterol Standard Deviation 0.17	1.02 Ratio of HDL-cholesterol Standard Deviation 0.18	1.04 Ratio of HDL-cholesterol Standard Deviation 0.15

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16	1.03 Ratio of non-HDL cholesterol Standard Deviation 0.16	0.93 Ratio of non-HDL cholesterol Standard Deviation 0.12	1.02 Ratio of non-HDL cholesterol Standard Deviation 0.16	1.09 Ratio of non-HDL cholesterol Standard Deviation 0.15	1.02 Ratio of non-HDL cholesterol Standard Deviation 0.15	1.04 Ratio of non-HDL cholesterol Standard Deviation 0.16

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52	1.00 Ratio of non-HDL cholesterol Standard Deviation 0.16	1.07 Ratio of non-HDL cholesterol Standard Deviation 0.13	1.02 Ratio of non-HDL cholesterol Standard Deviation 0.22	1.07 Ratio of non-HDL cholesterol Standard Deviation 0.19	1.01 Ratio of non-HDL cholesterol Standard Deviation 0.19	1.07 Ratio of non-HDL cholesterol Standard Deviation 0.17

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16	1.05 Ratio of VLDL cholesterol Standard Deviation 0.46	0.80 Ratio of VLDL cholesterol Standard Deviation 0.17	1.05 Ratio of VLDL cholesterol Standard Deviation 0.36	0.98 Ratio of VLDL cholesterol Standard Deviation 0.27	1.05 Ratio of VLDL cholesterol Standard Deviation 0.40	0.93 Ratio of VLDL cholesterol Standard Deviation 0.25

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52	1.03 Ratio of VLDL cholesterol Standard Deviation 0.26	1.13 Ratio of VLDL cholesterol Standard Deviation 0.31	1.06 Ratio of VLDL cholesterol Standard Deviation 0.35	0.95 Ratio of VLDL cholesterol Standard Deviation 0.36	1.04 Ratio of VLDL cholesterol Standard Deviation 0.31	1.01 Ratio of VLDL cholesterol Standard Deviation 0.34

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Triglycerides From Baseline at Week 16	1.05 Ratio of triglycerides Standard Deviation 0.44	0.80 Ratio of triglycerides Standard Deviation 0.18	1.04 Ratio of triglycerides Standard Deviation 0.36	0.99 Ratio of triglycerides Standard Deviation 0.26	1.05 Ratio of triglycerides Standard Deviation 0.39	0.93 Ratio of triglycerides Standard Deviation 0.25

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Triglycerides From Baseline at Week 52	1.04 Ratio of triglycerides Standard Deviation 0.29	1.12 Ratio of triglycerides Standard Deviation 0.32	1.07 Ratio of triglycerides Standard Deviation 0.36	0.94 Ratio of triglycerides Standard Deviation 0.36	1.06 Ratio of triglycerides Standard Deviation 0.32	1.00 Ratio of triglycerides Standard Deviation 0.35

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16	1.04 Ratio of FFA Standard Deviation 0.35	0.99 Ratio of FFA Standard Deviation 0.30	1.52 Ratio of FFA Standard Deviation 1.60	1.31 Ratio of FFA Standard Deviation 0.61	1.31 Ratio of FFA Standard Deviation 1.21	1.21 Ratio of FFA Standard Deviation 0.55

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=8 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52	0.85 Ratio of FFA Standard Deviation 0.51	1.05 Ratio of FFA Standard Deviation 0.25	1.15 Ratio of FFA Standard Deviation 0.76	1.45 Ratio of FFA Standard Deviation 0.49	1.01 Ratio of FFA Standard Deviation 0.67	1.32 Ratio of FFA Standard Deviation 0.45

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=33 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 SBP: Change from week 0 to week 16	2 Millimeters of mercury (mmHg) Standard Deviation 9	2 Millimeters of mercury (mmHg) Standard Deviation 6	-5 Millimeters of mercury (mmHg) Standard Deviation 15	-2 Millimeters of mercury (mmHg) Standard Deviation 13	-1 Millimeters of mercury (mmHg) Standard Deviation 13	-1 Millimeters of mercury (mmHg) Standard Deviation 11
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 DBP: Change from week 0 to week 16	1 Millimeters of mercury (mmHg) Standard Deviation 8	-1 Millimeters of mercury (mmHg) Standard Deviation 17	-1 Millimeters of mercury (mmHg) Standard Deviation 10	0 Millimeters of mercury (mmHg) Standard Deviation 7	0 Millimeters of mercury (mmHg) Standard Deviation 9	0 Millimeters of mercury (mmHg) Standard Deviation 11

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 SBP: Change from week 0 to week 52	4 Millimeters of mercury (mmHg) Standard Deviation 15	7 Millimeters of mercury (mmHg) Standard Deviation 8	-5 Millimeters of mercury (mmHg) Standard Deviation 6	4 Millimeters of mercury (mmHg) Standard Deviation 12	-1 Millimeters of mercury (mmHg) Standard Deviation 11	5 Millimeters of mercury (mmHg) Standard Deviation 11
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 DBP: Change from week 0 to week 52	4 Millimeters of mercury (mmHg) Standard Deviation 13	1 Millimeters of mercury (mmHg) Standard Deviation 7	-3 Millimeters of mercury (mmHg) Standard Deviation 9	5 Millimeters of mercury (mmHg) Standard Deviation 13	0 Millimeters of mercury (mmHg) Standard Deviation 11	4 Millimeters of mercury (mmHg) Standard Deviation 12

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HbA1c from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=29 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16	-0.2 Percentage point of HbA1c Standard Deviation 0.3	-0.2 Percentage point of HbA1c Standard Deviation 0.3	-0.2 Percentage point of HbA1c Standard Deviation 0.1	0 Percentage point of HbA1c Standard Deviation 0.3	-0.2 Percentage point of HbA1c Standard Deviation 0.2	-0.1 Percentage point of HbA1c Standard Deviation 0.3

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HbA1c from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=14 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in HbA1c From Baseline at Week 52	-0.2 Percentage point of HbA1c Standard Deviation 0.4	-0.1 Percentage point of HbA1c Standard Deviation 0.3	-0.2 Percentage point of HbA1c Standard Deviation 0.2	0.1 Percentage point of HbA1c Standard Deviation 0.3	-0.2 Percentage point of HbA1c Standard Deviation 0.3	0.1 Percentage point of HbA1c Standard Deviation 0.3

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in FPG from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16	-0.1 mmol/L Standard Deviation 0.5	0.2 mmol/L Standard Deviation 0.4	-0.2 mmol/L Standard Deviation 0.5	0.1 mmol/L Standard Deviation 0.5	-0.2 mmol/L Standard Deviation 0.5	0.1 mmol/L Standard Deviation 0.4

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in FPG from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=14 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in FPG From Baseline at Week 52	0 mmol/L Standard Deviation 0.4	0 mmol/L Standard Deviation 0.4	0 mmol/L Standard Deviation 0.7	0.3 mmol/L Standard Deviation 0.8	0 mmol/L Standard Deviation 0.6	0.2 mmol/L Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting Insulin From Baseline at Week 16	1.43 Ratio of fasting insulin Standard Deviation 1.17	1.32 Ratio of fasting insulin Standard Deviation 0.68	1.59 Ratio of fasting insulin Standard Deviation 1.91	0.78 Ratio of fasting insulin Standard Deviation 0.32	1.52 Ratio of fasting insulin Standard Deviation 1.62	0.97 Ratio of fasting insulin Standard Deviation 0.53

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=8 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting Insulin From Baseline at Week 52	1.45 Ratio of fasting insulin Standard Deviation 1.27	1.22 Ratio of fasting insulin Standard Deviation 0.44	2.03 Ratio of fasting insulin Standard Deviation 2.33	0.79 Ratio of fasting insulin Standard Deviation 0.37	1.78 Ratio of fasting insulin Standard Deviation 1.94	0.96 Ratio of fasting insulin Standard Deviation 0.44

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting C Peptide From Baseline at Week 16	1.11 Ratio of fasting C peptide Standard Deviation 0.50	1.08 Ratio of fasting C peptide Standard Deviation 0.44	1.14 Ratio of fasting C peptide Standard Deviation 0.56	0.86 Ratio of fasting C peptide Standard Deviation 0.20	1.13 Ratio of fasting C peptide Standard Deviation 0.53	0.94 Ratio of fasting C peptide Standard Deviation 0.31

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=8 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Fasting C Peptide From Baseline at Week 52	1.15 Ratio of fasting C peptide Standard Deviation 0.45	1.09 Ratio of fasting C peptide Standard Deviation 0.30	1.34 Ratio of fasting C peptide Standard Deviation 0.92	0.91 Ratio of fasting C peptide Standard Deviation 0.23	1.26 Ratio of fasting C peptide Standard Deviation 0.75	0.98 Ratio of fasting C peptide Standard Deviation 0.26

SECONDARY outcome

Timeframe: week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants in Glycaemic Category at Week 16 Normoglycaemia	11 Participants	5 Participants	16 Participants	8 Participants	27 Participants	13 Participants
Number of Participants in Glycaemic Category at Week 16 Pre-diabetes	2 Participants	2 Participants	2 Participants	4 Participants	4 Participants	6 Participants
Number of Participants in Glycaemic Category at Week 16 Type 2 diabetes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=14 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants in Glycaemic Category at Week 52 Normoglycaemia	10 Participants	2 Participants	13 Participants	4 Participants	23 Participants	6 Participants
Number of Participants in Glycaemic Category at Week 52 Pre-diabetes	2 Participants	3 Participants	2 Participants	4 Participants	4 Participants	7 Participants
Number of Participants in Glycaemic Category at Week 52 Type 2 diabetes	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16	1.55 Ratio of HOMA-B Standard Deviation 1.04	1.07 Ratio of HOMA-B Standard Deviation 0.51	1.69 Ratio of HOMA-B Standard Deviation 1.93	0.70 Ratio of HOMA-B Standard Deviation 0.31	1.63 Ratio of HOMA-B Standard Deviation 1.59	0.82 Ratio of HOMA-B Standard Deviation 0.41

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=8 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52	1.50 Ratio of HOMA-B Standard Deviation 1.50	1.25 Ratio of HOMA-B Standard Deviation 0.50	2.24 Ratio of HOMA-B Standard Deviation 1.85	0.65 Ratio of HOMA-B Standard Deviation 0.30	1.91 Ratio of HOMA-B Standard Deviation 1.71	0.88 Ratio of HOMA-B Standard Deviation 0.48

SECONDARY outcome

Timeframe: Week 0, week 16

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16	1.43 Ratio of HOMA-IR Standard Deviation 1.26	1.33 Ratio of HOMA-IR Standard Deviation 0.82	1.57 Ratio of HOMA-IR Standard Deviation 1.92	0.80 Ratio of HOMA-IR Standard Deviation 0.35	1.51 Ratio of HOMA-IR Standard Deviation 1.65	0.97 Ratio of HOMA-IR Standard Deviation 0.58

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=8 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52	1.45 Ratio of HOMA-IR Standard Deviation 1.23	1.24 Ratio of HOMA-IR Standard Deviation 0.48	2.26 Ratio of HOMA-IR Standard Deviation 3.13	0.88 Ratio of HOMA-IR Standard Deviation 0.50	1.90 Ratio of HOMA-IR Standard Deviation 2.46	1.02 Ratio of HOMA-IR Standard Deviation 0.51

SECONDARY outcome

Timeframe: From week 0 to week 54

Population: Safety analysis set (SAS) which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)).

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Treatment Emergent Adverse Events	159 Events	8 Events	134 Events	37 Events	293 Events	45 Events

SECONDARY outcome

Timeframe: From week 0 to week 54

Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Severe Treatment Emergent Episodes of Hypoglycaemia	1 Episodes	0 Episodes	0 Episodes	0 Episodes	1 Episodes	0 Episodes

SECONDARY outcome

Timeframe: From week 0 to week 54

Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia	0 Episodes	0 Episodes	0 Episodes	0 Episodes	0 Episodes	0 Episodes

SECONDARY outcome

Timeframe: From week 0 to week 54

Population: SAS which included all participants exposed to at least one dose of trial product. Overall number of participants analysed = Number of participants with available data. Combined data of Part A and B for liraglutide was planned to be reported.

Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies.

Outcome measures

Measure	Part B: Liraglutide n=25 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Occurrence of Anti-liraglutide Antibodies Yes	3 Participants	—	2 Participants	1 Participants	—	—
Number of Participants With Occurrence of Anti-liraglutide Antibodies No	22 Participants	—	14 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Week 0, Week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented.

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 Week 0: Abnormal, NCS	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 Week 16: Normal	13 Participants	7 Participants	17 Participants	12 Participants	30 Participants	19 Participants
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 Week 0: Normal	17 Participants	6 Participants	20 Participants	12 Participants	37 Participants	18 Participants
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 Week 0: Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 Week 16: Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 Week 16: Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented.

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Change in ECG From Baseline at Week 52 Week 0: Normal	17 Participants	6 Participants	20 Participants	12 Participants	37 Participants	18 Participants
Number of Participants With Change in ECG From Baseline at Week 52 Week 0: Abnormal, NCS	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Change in ECG From Baseline at Week 52 Week 0: Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in ECG From Baseline at Week 52 Week 52: Normal	13 Participants	4 Participants	17 Participants	9 Participants	30 Participants	13 Participants
Number of Participants With Change in ECG From Baseline at Week 52 Week 52: Abnormal, NCS	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Change in ECG From Baseline at Week 52 Week 52: Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in pulse from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=33 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Pulse From Baseline at Week 16	1 Beats/minute Standard Deviation 16	-9 Beats/minute Standard Deviation 10	2 Beats/minute Standard Deviation 12	-2 Beats/minute Standard Deviation 5	2 Beats/minute Standard Deviation 14	-4 Beats/minute Standard Deviation 8

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in pulse from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Pulse From Baseline at Week 52	10 Beats/minute Standard Deviation 11	-6 Beats/minute Standard Deviation 8	1 Beats/minute Standard Deviation 13	-8 Beats/minute Standard Deviation 10	5 Beats/minute Standard Deviation 13	-7 Beats/minute Standard Deviation 10

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in haemoglobin from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Haemoglobin From Baseline at Week 16	-0.20 millimoles per liter (mmol/L) Standard Deviation 1.22	-0.07 millimoles per liter (mmol/L) Standard Deviation 0.55	-0.18 millimoles per liter (mmol/L) Standard Deviation 0.43	0.06 millimoles per liter (mmol/L) Standard Deviation 0.28	-0.19 millimoles per liter (mmol/L) Standard Deviation 0.84	0.01 millimoles per liter (mmol/L) Standard Deviation 0.38

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in haemoglobin from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=10 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=25 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Haemoglobin From Baseline at Week 52	-0.02 mmol/L Standard Deviation 0.61	-0.02 mmol/L Standard Deviation 0.20	-0.14 mmol/L Standard Deviation 0.79	-0.01 mmol/L Standard Deviation 0.31	-0.09 mmol/L Standard Deviation 0.72	-0.01 mmol/L Standard Deviation 0.28

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in haematocrit from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Haematocrit From Baseline at Week 16	0.4 Percentage of haematocrit in blood Standard Deviation 2.6	-0.6 Percentage of haematocrit in blood Standard Deviation 3.3	-1.8 Percentage of haematocrit in blood Standard Deviation 2.1	-0.5 Percentage of haematocrit in blood Standard Deviation 1.3	-0.9 Percentage of haematocrit in blood Standard Deviation 2.6	-0.5 Percentage of haematocrit in blood Standard Deviation 2.1

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in haematocrit from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=10 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=25 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Haematocrit From Baseline at Week 52	-0.2 Percentage of haematocrit in blood Standard Deviation 2.7	-0.8 Percentage of haematocrit in blood Standard Deviation 2.6	-1.4 Percentage of haematocrit in blood Standard Deviation 4.0	0 Percentage of haematocrit in blood Standard Deviation 1.7	-0.9 Percentage of haematocrit in blood Standard Deviation 3.5	-0.3 Percentage of haematocrit in blood Standard Deviation 1.9

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Thrombocytes: Change from week 0 to week 16	8 10^9 cells per liter (10^9/L) Standard Deviation 66	19 10^9 cells per liter (10^9/L) Standard Deviation 18	6 10^9 cells per liter (10^9/L) Standard Deviation 35	-21 10^9 cells per liter (10^9/L) Standard Deviation 26	7 10^9 cells per liter (10^9/L) Standard Deviation 49	-8 10^9 cells per liter (10^9/L) Standard Deviation 30
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Leukocytes: Change from week 0 to week 16	-0.8 10^9 cells per liter (10^9/L) Standard Deviation 2.3	-1.1 10^9 cells per liter (10^9/L) Standard Deviation 1.7	-0.1 10^9 cells per liter (10^9/L) Standard Deviation 1.5	-0.3 10^9 cells per liter (10^9/L) Standard Deviation 1.6	-0.4 10^9 cells per liter (10^9/L) Standard Deviation 1.9	-0.6 10^9 cells per liter (10^9/L) Standard Deviation 1.6
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Eosinophils: Change from week 0 to week 16	-0.14 10^9 cells per liter (10^9/L) Standard Deviation 0.27	0.07 10^9 cells per liter (10^9/L) Standard Deviation 0.32	-0.03 10^9 cells per liter (10^9/L) Standard Deviation 0.09	0.04 10^9 cells per liter (10^9/L) Standard Deviation 0.07	-0.07 10^9 cells per liter (10^9/L) Standard Deviation 0.20	0.05 10^9 cells per liter (10^9/L) Standard Deviation 0.19
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Neutrophils: Change from week 0 to week 16	-0.28 10^9 cells per liter (10^9/L) Standard Deviation 1.59	-1.35 10^9 cells per liter (10^9/L) Standard Deviation 1.33	0.11 10^9 cells per liter (10^9/L) Standard Deviation 1.08	-0.22 10^9 cells per liter (10^9/L) Standard Deviation 1.62	-0.06 10^9 cells per liter (10^9/L) Standard Deviation 1.31	-0.62 10^9 cells per liter (10^9/L) Standard Deviation 1.58
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Basophils: Change from week 0 to week 16	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.04	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.04	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.02	0 10^9 cells per liter (10^9/L) Standard Deviation 0.02	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.03	0 10^9 cells per liter (10^9/L) Standard Deviation 0.03
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Lymphocytes: Change from week 0 to week 16	-0.36 10^9 cells per liter (10^9/L) Standard Deviation 0.89	0.09 10^9 cells per liter (10^9/L) Standard Deviation 0.85	-0.24 10^9 cells per liter (10^9/L) Standard Deviation 0.66	-0.09 10^9 cells per liter (10^9/L) Standard Deviation 0.97	-0.29 10^9 cells per liter (10^9/L) Standard Deviation 0.76	-0.02 10^9 cells per liter (10^9/L) Standard Deviation 0.91
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 Monocytes: Change from week 0 to week 16	-0.05 10^9 cells per liter (10^9/L) Standard Deviation 0.17	0.05 10^9 cells per liter (10^9/L) Standard Deviation 0.20	0.06 10^9 cells per liter (10^9/L) Standard Deviation 0.17	-0.04 10^9 cells per liter (10^9/L) Standard Deviation 0.12	0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.18	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.15

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=10 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=25 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Thrombocytes: Change from week 0 to week 52	-2 10^9 cells per liter (10^9/L) Standard Deviation 37	37 10^9 cells per liter (10^9/L) Standard Deviation 70	18 10^9 cells per liter (10^9/L) Standard Deviation 44	-7 10^9 cells per liter (10^9/L) Standard Deviation 39	10 10^9 cells per liter (10^9/L) Standard Deviation 42	5 10^9 cells per liter (10^9/L) Standard Deviation 49
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Neutrophils: Change from week 0 to week 52	-0.03 10^9 cells per liter (10^9/L) Standard Deviation 2.03	-0.07 10^9 cells per liter (10^9/L) Standard Deviation 2.55	0.11 10^9 cells per liter (10^9/L) Standard Deviation 1.17	-0.76 10^9 cells per liter (10^9/L) Standard Deviation 1.40	0.05 10^9 cells per liter (10^9/L) Standard Deviation 1.53	-0.55 10^9 cells per liter (10^9/L) Standard Deviation 1.75
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Lymphocytes: Change from week 0 to week 52	-0.47 10^9 cells per liter (10^9/L) Standard Deviation 0.59	0.39 10^9 cells per liter (10^9/L) Standard Deviation 0.49	-0.28 10^9 cells per liter (10^9/L) Standard Deviation 0.67	0.19 10^9 cells per liter (10^9/L) Standard Deviation 0.70	-0.36 10^9 cells per liter (10^9/L) Standard Deviation 0.63	0.25 10^9 cells per liter (10^9/L) Standard Deviation 0.63
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Leukocytes: Change from week 0 to week 52	-0.7 10^9 cells per liter (10^9/L) Standard Deviation 2.8	0.3 10^9 cells per liter (10^9/L) Standard Deviation 3.0	-0.2 10^9 cells per liter (10^9/L) Standard Deviation 1.1	-0.6 10^9 cells per liter (10^9/L) Standard Deviation 1.7	-0.4 10^9 cells per liter (10^9/L) Standard Deviation 1.9	-0.3 10^9 cells per liter (10^9/L) Standard Deviation 2.1
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Eosinophils: Change from week 0 to week 52	-0.13 10^9 cells per liter (10^9/L) Standard Deviation 0.36	-0.17 10^9 cells per liter (10^9/L) Standard Deviation 0.13	0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.11	0.03 10^9 cells per liter (10^9/L) Standard Deviation 0.19	-0.05 10^9 cells per liter (10^9/L) Standard Deviation 0.24	-0.03 10^9 cells per liter (10^9/L) Standard Deviation 0.20
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Basophils: Change from week 0 to week 52	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.04	0.02 10^9 cells per liter (10^9/L) Standard Deviation 0.04	0 10^9 cells per liter (10^9/L) Standard Deviation 0.03	0 10^9 cells per liter (10^9/L) Standard Deviation 0.04	-0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.04	0.01 10^9 cells per liter (10^9/L) Standard Deviation 0.04
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 Monocytes: Change from week 0 to week 52	-0.05 10^9 cells per liter (10^9/L) Standard Deviation 0.19	0.14 10^9 cells per liter (10^9/L) Standard Deviation 0.20	-0.04 10^9 cells per liter (10^9/L) Standard Deviation 0.19	-0.06 10^9 cells per liter (10^9/L) Standard Deviation 0.22	-0.04 10^9 cells per liter (10^9/L) Standard Deviation 0.19	0 10^9 cells per liter (10^9/L) Standard Deviation 0.23

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in erythrocytes from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Erythrocytes From Baseline at Week 16	0.1 10^12 cells per liter (10^12/L) Standard Deviation 0.3	0 10^12 cells per liter (10^12/L) Standard Deviation 0.3	-0.1 10^12 cells per liter (10^12/L) Standard Deviation 0.2	0 10^12 cells per liter (10^12/L) Standard Deviation 0.2	-0.1 10^12 cells per liter (10^12/L) Standard Deviation 0.3	0 10^12 cells per liter (10^12/L) Standard Deviation 0.2

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in erythrocytes from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=10 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=25 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=13 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Haematology: Erythrocytes From Baseline at Week 52	-0.1 10^12 cells per liter (10^12/L) Standard Deviation 0.3	0 10^12 cells per liter (10^12/L) Standard Deviation 0	-0.1 10^12 cells per liter (10^12/L) Standard Deviation 0.4	0 10^12 cells per liter (10^12/L) Standard Deviation 0.2	-0.1 10^12 cells per liter (10^12/L) Standard Deviation 0.4	0 10^12 cells per liter (10^12/L) Standard Deviation 0.1

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in creatinine and bilirubin (total) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 Creatinine: Change from week 0 to week 16	2 micro mole per liter (umol/L) Standard Deviation 7	0 micro mole per liter (umol/L) Standard Deviation 6	1 micro mole per liter (umol/L) Standard Deviation 5	0 micro mole per liter (umol/L) Standard Deviation 6	1 micro mole per liter (umol/L) Standard Deviation 5	0 micro mole per liter (umol/L) Standard Deviation 6
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 Bilirubin (total): Change from week 0 to week 16	0 micro mole per liter (umol/L) Standard Deviation 2	1 micro mole per liter (umol/L) Standard Deviation 2	0 micro mole per liter (umol/L) Standard Deviation 2	0 micro mole per liter (umol/L) Standard Deviation 2	0 micro mole per liter (umol/L) Standard Deviation 2	0 micro mole per liter (umol/L) Standard Deviation 2

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in creatinine and bilirubin (total) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 Creatinine: Change from week 0 to week 52	3 umol/L Standard Deviation 6	5 umol/L Standard Deviation 3	3 umol/L Standard Deviation 8	-4 umol/L Standard Deviation 9	3 umol/L Standard Deviation 7	-1 umol/L Standard Deviation 9
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 Bilirubin (total): Change from week 0 to week 52	0 umol/L Standard Deviation 1	2 umol/L Standard Deviation 3	0 umol/L Standard Deviation 2	2 umol/L Standard Deviation 3	0 umol/L Standard Deviation 2	2 umol/L Standard Deviation 3

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 Creatinine kinase: Change from week 0 to week 16	3 Units per liter (U/L) Standard Deviation 23	-5 Units per liter (U/L) Standard Deviation 5	-3 Units per liter (U/L) Standard Deviation 37	16 Units per liter (U/L) Standard Deviation 45	-1 Units per liter (U/L) Standard Deviation 32	10 Units per liter (U/L) Standard Deviation 39
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 AST: Change from week 0 to week 16	-2 Units per liter (U/L) Standard Deviation 5	-18 Units per liter (U/L) Standard Deviation 24	-6 Units per liter (U/L) Standard Deviation 14	0 Units per liter (U/L) Standard Deviation 10	-4 Units per liter (U/L) Standard Deviation 11	-6 Units per liter (U/L) Standard Deviation 17
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 Amylase: Change from week 0 to week 16	8 Units per liter (U/L) Standard Deviation 12	8 Units per liter (U/L) Standard Deviation 8	5 Units per liter (U/L) Standard Deviation 13	-2 Units per liter (U/L) Standard Deviation 5	6 Units per liter (U/L) Standard Deviation 13	1 Units per liter (U/L) Standard Deviation 8
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 Lipase: Change from week 0 to week 16	8 Units per liter (U/L) Standard Deviation 7	1 Units per liter (U/L) Standard Deviation 2	10 Units per liter (U/L) Standard Deviation 6	0 Units per liter (U/L) Standard Deviation 4	9 Units per liter (U/L) Standard Deviation 6	0 Units per liter (U/L) Standard Deviation 3
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 ALT: Change from week 0 to week 16	-2 Units per liter (U/L) Standard Deviation 6	-25 Units per liter (U/L) Standard Deviation 23	-9 Units per liter (U/L) Standard Deviation 32	-4 Units per liter (U/L) Standard Deviation 18	-6 Units per liter (U/L) Standard Deviation 25	-10 Units per liter (U/L) Standard Deviation 21
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 ALP: Change from week 0 to week 16	-21 Units per liter (U/L) Standard Deviation 36	-47 Units per liter (U/L) Standard Deviation 42	-10 Units per liter (U/L) Standard Deviation 12	-7 Units per liter (U/L) Standard Deviation 25	-14 Units per liter (U/L) Standard Deviation 24	-19 Units per liter (U/L) Standard Deviation 35

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 Amylase: Change from week 0 to week 52	7 Units per liter (U/L) Standard Deviation 12	8 Units per liter (U/L) Standard Deviation 5	4 Units per liter (U/L) Standard Deviation 10	2 Units per liter (U/L) Standard Deviation 12	5 Units per liter (U/L) Standard Deviation 11	4 Units per liter (U/L) Standard Deviation 11
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 ALT: Change from week 0 to week 52	0 Units per liter (U/L) Standard Deviation 16	-24 Units per liter (U/L) Standard Deviation 28	1 Units per liter (U/L) Standard Deviation 12	4 Units per liter (U/L) Standard Deviation 25	1 Units per liter (U/L) Standard Deviation 14	-6 Units per liter (U/L) Standard Deviation 29
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 AST: Change from week 0 to week 52	1 Units per liter (U/L) Standard Deviation 7	-21 Units per liter (U/L) Standard Deviation 32	-2 Units per liter (U/L) Standard Deviation 7	9 Units per liter (U/L) Standard Deviation 31	-1 Units per liter (U/L) Standard Deviation 7	0 Units per liter (U/L) Standard Deviation 33
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 ALP: Change from week 0 to week 52	-25 Units per liter (U/L) Standard Deviation 59	-26 Units per liter (U/L) Standard Deviation 60	-24 Units per liter (U/L) Standard Deviation 27	-35 Units per liter (U/L) Standard Deviation 27	-24 Units per liter (U/L) Standard Deviation 42	-32 Units per liter (U/L) Standard Deviation 39
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 Creatinine kinase: Change from week 0 to week 52	25 Units per liter (U/L) Standard Deviation 42	-8 Units per liter (U/L) Standard Deviation 25	30 Units per liter (U/L) Standard Deviation 206	-4 Units per liter (U/L) Standard Deviation 29	28 Units per liter (U/L) Standard Deviation 159	-5 Units per liter (U/L) Standard Deviation 27
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 Lipase: Change from week 0 to week 52	7 Units per liter (U/L) Standard Deviation 6	3 Units per liter (U/L) Standard Deviation 5	9 Units per liter (U/L) Standard Deviation 9	-1 Units per liter (U/L) Standard Deviation 3	8 Units per liter (U/L) Standard Deviation 8	0 Units per liter (U/L) Standard Deviation 4

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 Sodium: Change from week 0 to week 16	1 mmol/L Standard Deviation 4	0 mmol/L Standard Deviation 1	0 mmol/L Standard Deviation 5	2 mmol/L Standard Deviation 3	0 mmol/L Standard Deviation 4	1 mmol/L Standard Deviation 3
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 Urea: Change from week 0 to week 16	0 mmol/L Standard Deviation 0.99	0.09 mmol/L Standard Deviation 2.19	0.03 mmol/L Standard Deviation 1.45	-0.51 mmol/L Standard Deviation 0.67	0.02 mmol/L Standard Deviation 1.26	-0.31 mmol/L Standard Deviation 1.33
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 Potassium: Change from week 0 to week 16	-0.2 mmol/L Standard Deviation 0.6	-0.1 mmol/L Standard Deviation 0.2	0.1 mmol/L Standard Deviation 0.4	-0.1 mmol/L Standard Deviation 0.3	0 mmol/L Standard Deviation 0.5	-0.1 mmol/L Standard Deviation 0.2
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 Calcium: Change from week 0 to week 16	0.08 mmol/L Standard Deviation 0.17	0.02 mmol/L Standard Deviation 0.10	0 mmol/L Standard Deviation 0.12	0 mmol/L Standard Deviation 0.10	0.03 mmol/L Standard Deviation 0.14	0.01 mmol/L Standard Deviation 0.10

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 Urea: Change from week 0 to week 52	-0.21 mmol/L Standard Deviation 1.00	-0.04 mmol/L Standard Deviation 1.08	-0.38 mmol/L Standard Deviation 1.56	-0.34 mmol/L Standard Deviation 0.54	-0.31 mmol/L Standard Deviation 1.34	-0.24 mmol/L Standard Deviation 0.74
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 Sodium: Change from week 0 to week 52	1 mmol/L Standard Deviation 4	2 mmol/L Standard Deviation 2	-1 mmol/L Standard Deviation 5	-2 mmol/L Standard Deviation 5	0 mmol/L Standard Deviation 4	-1 mmol/L Standard Deviation 4
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 Potassium: Change from week 0 to week 52	-0.2 mmol/L Standard Deviation 0.7	0 mmol/L Standard Deviation 0.2	-0.2 mmol/L Standard Deviation 0.6	-0.1 mmol/L Standard Deviation 0.2	-0.2 mmol/L Standard Deviation 0.6	-0.1 mmol/L Standard Deviation 0.2
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 Calcium: Change from week 0 to week 52	0.09 mmol/L Standard Deviation 0.14	0 mmol/L Standard Deviation 0.02	-0.05 mmol/L Standard Deviation 0.14	-0.11 mmol/L Standard Deviation 0.12	0.01 mmol/L Standard Deviation 0.15	-0.08 mmol/L Standard Deviation 0.11

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in albumin from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Albumin From Baseline at Week 16	0 gram per deciliter (g/dL) Standard Deviation 0.2	0 gram per deciliter (g/dL) Standard Deviation 0.1	0 gram per deciliter (g/dL) Standard Deviation 0.2	0 gram per deciliter (g/dL) Standard Deviation 0.1	0 gram per deciliter (g/dL) Standard Deviation 0.2	0 gram per deciliter (g/dL) Standard Deviation 0.1

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in albumin from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Biochemistry: Albumin From Baseline at Week 52	0 g/dL Standard Deviation 0.2	0 g/dL Standard Deviation 0.1	-0.1 g/dL Standard Deviation 0.7	-0.1 g/dL Standard Deviation 0.3	0 g/dL Standard Deviation 0.5	-0.1 g/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in CEA serum from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16	0.17 nanogram per milliliter (ng/mL) Standard Deviation 0.55	-0.04 nanogram per milliliter (ng/mL) Standard Deviation 0.10	-0.01 nanogram per milliliter (ng/mL) Standard Deviation 0.11	-0.17 nanogram per milliliter (ng/mL) Standard Deviation 0.30	0.07 nanogram per milliliter (ng/mL) Standard Deviation 0.38	-0.12 nanogram per milliliter (ng/mL) Standard Deviation 0.24

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in CEA serum from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=15 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52	-0.01 ng/mL Standard Deviation 0.14	0.17 ng/mL Standard Deviation 0.24	0.03 ng/mL Standard Deviation 0.38	-0.14 ng/mL Standard Deviation 0.26	0.01 ng/mL Standard Deviation 0.29	-0.01 ng/mL Standard Deviation 0.29

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in calcitonin from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Calcitonin From Baseline at Week 16	0.3 nanogram per liter (ng/L) Standard Deviation 1.1	0 nanogram per liter (ng/L) Standard Deviation 0	0 nanogram per liter (ng/L) Standard Deviation 0	0 nanogram per liter (ng/L) Standard Deviation 0	0.1 nanogram per liter (ng/L) Standard Deviation 0.7	0 nanogram per liter (ng/L) Standard Deviation 0

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in calcitonin from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Calcitonin From Baseline at Week 52	0.5 ng/L Standard Deviation 1.2	0 ng/L Standard Deviation 0	0.1 ng/L Standard Deviation 0.6	0 ng/L Standard Deviation 0	0.3 ng/L Standard Deviation 0.9	0 ng/L Standard Deviation 0

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in TSH and prolactin from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 TSH: Change from week 0 to week 16	-0.09 Milli-international units/liter (mIU/L) Standard Deviation 1.13	-0.59 Milli-international units/liter (mIU/L) Standard Deviation 0.67	-0.34 Milli-international units/liter (mIU/L) Standard Deviation 0.68	-0.01 Milli-international units/liter (mIU/L) Standard Deviation 0.72	-0.23 Milli-international units/liter (mIU/L) Standard Deviation 0.89	-0.23 Milli-international units/liter (mIU/L) Standard Deviation 0.74
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 Prolactin: Change from week 0 to week 16	0 Milli-international units/liter (mIU/L) Standard Deviation 13	-22 Milli-international units/liter (mIU/L) Standard Deviation 63	7 Milli-international units/liter (mIU/L) Standard Deviation 27	-6 Milli-international units/liter (mIU/L) Standard Deviation 33	4 Milli-international units/liter (mIU/L) Standard Deviation 22	-12 Milli-international units/liter (mIU/L) Standard Deviation 45

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in TSH and prolactin from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 TSH: Change from week 0 to week 52	-0.75 mIU/L Standard Deviation 2.13	-0.17 mIU/L Standard Deviation 1.08	0.02 mIU/L Standard Deviation 1.59	-0.48 mIU/L Standard Deviation 0.63	-0.30 mIU/L Standard Deviation 1.83	-0.38 mIU/L Standard Deviation 0.78
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 Prolactin: Change from week 0 to week 52	-3 mIU/L Standard Deviation 37	29 mIU/L Standard Deviation 33	10 mIU/L Standard Deviation 38	8 mIU/L Standard Deviation 37	5 mIU/L Standard Deviation 37	15 mIU/L Standard Deviation 36

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in free T4 and ACTH from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 T4: Change from week 0 to week 16	0.7 picomole per liter (pmol/L) Standard Deviation 2.3	0.1 picomole per liter (pmol/L) Standard Deviation 1.7	-0.6 picomole per liter (pmol/L) Standard Deviation 1.4	0.3 picomole per liter (pmol/L) Standard Deviation 1.1	-0.1 picomole per liter (pmol/L) Standard Deviation 1.9	0.2 picomole per liter (pmol/L) Standard Deviation 1.3
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 ACTH: Change from week 0 to week 16	-0.37 picomole per liter (pmol/L) Standard Deviation 1.49	-1.32 picomole per liter (pmol/L) Standard Deviation 1.87	0.99 picomole per liter (pmol/L) Standard Deviation 5.22	-0.85 picomole per liter (pmol/L) Standard Deviation 2.22	0.42 picomole per liter (pmol/L) Standard Deviation 4.10	-1.02 picomole per liter (pmol/L) Standard Deviation 2.04

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in free T4 and ACTH from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 T4: Change from week 0 to week 52	-0.1 pmol/L Standard Deviation 2.0	0.8 pmol/L Standard Deviation 2.3	-0.4 pmol/L Standard Deviation 1.7	1.9 pmol/L Standard Deviation 2.7	-0.3 pmol/L Standard Deviation 1.8	1.5 pmol/L Standard Deviation 2.5
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 ACTH: Change from week 0 to week 52	0.98 pmol/L Standard Deviation 5.64	0.20 pmol/L Standard Deviation 2.41	-0.02 pmol/L Standard Deviation 2.02	1.29 pmol/L Standard Deviation 3.50	0.42 pmol/L Standard Deviation 3.99	0.89 pmol/L Standard Deviation 3.07

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in IGF-1 and cortisol from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=18 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 IGF-1: Change from week 0 to week 16	2.41 nanogram per milliliter (ng/mL) Standard Deviation 84.98	-14.23 nanogram per milliliter (ng/mL) Standard Deviation 75.01	-56.89 nanogram per milliliter (ng/mL) Standard Deviation 126.46	-28.23 nanogram per milliliter (ng/mL) Standard Deviation 95.79	-30.31 nanogram per milliliter (ng/mL) Standard Deviation 112.09	-23.86 nanogram per milliliter (ng/mL) Standard Deviation 87.54
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 Cortisol: Change from week 0 to week 16	-8.09 nanogram per milliliter (ng/mL) Standard Deviation 22.98	-23.08 nanogram per milliliter (ng/mL) Standard Deviation 59.02	-22.94 nanogram per milliliter (ng/mL) Standard Deviation 41.36	6.75 nanogram per milliliter (ng/mL) Standard Deviation 38.72	-16.71 nanogram per milliliter (ng/mL) Standard Deviation 35.16	-4.85 nanogram per milliliter (ng/mL) Standard Deviation 48.33

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in IGF-1 and cortisol from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=9 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=14 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 IGF-1: Change from week 0 to week 52	-1.47 ng/mL Standard Deviation 112.93	10.40 ng/mL Standard Deviation 56.69	-25.90 ng/mL Standard Deviation 195.61	-103.45 ng/mL Standard Deviation 136.61	-15.04 ng/mL Standard Deviation 161.72	-59.66 ng/mL Standard Deviation 123.62
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 Cortisol: Change from week 0 to week 52	-14.15 ng/mL Standard Deviation 43.84	21.67 ng/mL Standard Deviation 46.62	3.60 ng/mL Standard Deviation 50.63	7.54 ng/mL Standard Deviation 33.71	-4.01 ng/mL Standard Deviation 47.82	12.59 ng/mL Standard Deviation 37.65

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in DHEAS from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=16 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16	0.25 umol/L Standard Deviation 1.10	1.00 umol/L Standard Deviation 1.42	0.16 umol/L Standard Deviation 1.74	0.21 umol/L Standard Deviation 0.95	0.20 umol/L Standard Deviation 1.48	0.46 umol/L Standard Deviation 1.13

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in DHEAS from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=12 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=8 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=28 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52	0.25 umol/L Standard Deviation 0.66	0.74 umol/L Standard Deviation 1.26	0.77 umol/L Standard Deviation 1.18	0.76 umol/L Standard Deviation 0.97	0.55 umol/L Standard Deviation 1.01	0.76 umol/L Standard Deviation 1.01

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in LH and FSH from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=13 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=30 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 LH: Change from week 0 to week 16	-0.07 IU/L Standard Deviation 0.25	0.22 IU/L Standard Deviation 0.42	-0.04 IU/L Standard Deviation 1.28	0.06 IU/L Standard Deviation 0.74	-0.05 IU/L Standard Deviation 0.97	0.12 IU/L Standard Deviation 0.63
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 FSH: Change from week 0 to week 16	-0.1 IU/L Standard Deviation 1.3	1.0 IU/L Standard Deviation 1.1	-0.2 IU/L Standard Deviation 2.5	0.2 IU/L Standard Deviation 1.0	-0.2 IU/L Standard Deviation 2.1	0.5 IU/L Standard Deviation 1.1

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in LH and FSH from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=10 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=27 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=15 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 FSH: Change from week 0 to week 52	0.4 IU/L Standard Deviation 1.8	0.7 IU/L Standard Deviation 1.6	1.1 IU/L Standard Deviation 3.9	0.4 IU/L Standard Deviation 1.6	0.8 IU/L Standard Deviation 3.1	0.6 IU/L Standard Deviation 1.5
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 LH: Change from week 0 to week 52	0.37 IU/L Standard Deviation 0.96	0.30 IU/L Standard Deviation 0.51	0.16 IU/L Standard Deviation 2.33	0.06 IU/L Standard Deviation 0.79	0.24 IU/L Standard Deviation 1.87	0.14 IU/L Standard Deviation 0.70

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of female participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in estradiol (only for females) from baseline to week 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=6 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=2 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=9 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=15 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Estradiol (Females) From Baseline at Week 16	1.6 picograms per milliliter (pg/mL) Standard Deviation 3.8	0 picograms per milliliter (pg/mL) Standard Deviation 0	0.9 picograms per milliliter (pg/mL) Standard Deviation 15.8	9.2 picograms per milliliter (pg/mL) Standard Deviation 11.9	1.2 picograms per milliliter (pg/mL) Standard Deviation 12.2	6.1 picograms per milliliter (pg/mL) Standard Deviation 10.4

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of female participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Change in estradiol (only for females) from baseline to week 52 is presented.

Outcome measures

Measure	Part B: Liraglutide n=8 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=1 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=7 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=4 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=15 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Estradiol (Females) From Baseline at Week 52	1.6 pg/mL Standard Deviation 4.5	0 pg/mL Standard Deviation NA As there was only one participant evaluated for the Part B: Placebo arm; Mean and SD could not be calculated.	7.0 pg/mL Standard Deviation 32.6	13.7 pg/mL Standard Deviation 21.6	4.1 pg/mL Standard Deviation 21.8	11.0 pg/mL Standard Deviation 19.7

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of male participants who contributed to the analysis.

Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.

Outcome measures

Measure	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=8 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Testosterone (Males) From Baseline at Week 16	—	—	1.55 nanomoles per liter (nmol/L) Standard Deviation 2.01	0.61 nanomoles per liter (nmol/L) Standard Deviation 1.66	—	—

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of male participants who contributed to the analysis.

Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.

Outcome measures

Measure	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=8 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Change in Hormone Level: Testosterone (Males) From Baseline at Week 52	—	—	0.62 nmol/L Standard Deviation 1.40	-0.34 nmol/L Standard Deviation 1.51	—	—

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=22 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for female) · Stage 1	3 Participants	1 Participants	1 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for female) · Stage 2	5 Participants	0 Participants	1 Participants	0 Participants	6 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for female) · Stage 3	0 Participants	1 Participants	4 Participants	1 Participants	4 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for male) · Stage 1	6 Participants	3 Participants	0 Participants	0 Participants	6 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for male) · Stage 2	0 Participants	1 Participants	3 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for male) · Stage 3	0 Participants	1 Participants	2 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for male) · Stage 4	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for male) · Stage 3	0 Participants	1 Participants	2 Participants	3 Participants	2 Participants	4 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for male) · Stage 4	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Penis development (for male) · Stage 3	0 Participants	0 Participants	2 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Breast development (for female) · Stage 2	3 Participants	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for female) · Stage 4	2 Participants	0 Participants	3 Participants	1 Participants	5 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for female) · Stage 4	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for male) · Stage 2	0 Participants	3 Participants	2 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for male) · Stage 5	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for male) · Stage 1	6 Participants	1 Participants	0 Participants	0 Participants	6 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Pubic hair development (for male) · Stage 5	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Penis development (for male) · Stage 2	0 Participants	0 Participants	4 Participants	3 Participants	4 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Penis development (for male) · Stage 1	6 Participants	5 Participants	0 Participants	1 Participants	6 Participants	6 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Penis development (for male) · Stage 5	0 Participants	0 Participants	3 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Penis development (for male) · Stage 3	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Penis development (for male) · Stage 4	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Penis development (for male) · Stage 5	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Penis development (for male) · Stage 1	5 Participants	5 Participants	0 Participants	1 Participants	5 Participants	6 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Penis development (for male) · Stage 2	1 Participants	0 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Penis development (for male) · Stage 4	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Breast development (for female) · Stage 1	11 Participants	2 Participants	0 Participants	0 Participants	11 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Breast development (for female) · Stage 2	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Breast development (for female) · Stage 3	0 Participants	0 Participants	8 Participants	2 Participants	8 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Breast development (for female) · Stage 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Breast development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Breast development (for female) · Stage 1	6 Participants	2 Participants	0 Participants	0 Participants	6 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Breast development (for female) · Stage 3	0 Participants	0 Participants	7 Participants	1 Participants	7 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Breast development (for female) · Stage 4	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 16: Breast development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for female) · Stage 1	6 Participants	1 Participants	1 Participants	0 Participants	7 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for female) · Stage 2	3 Participants	0 Participants	2 Participants	0 Participants	5 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 16 Week 0: Pubic hair development (for female) · Stage 3	0 Participants	1 Participants	3 Participants	2 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".

Outcome measures

Measure	Part B: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=5 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=11 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=22 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Breast development (for female) · Stage 1	11 Participants	2 Participants	0 Participants	0 Participants	11 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Penis development (for male) · Stage 4	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Breast development (for female) · Stage 2	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Breast development (for female) · Stage 3	0 Participants	0 Participants	8 Participants	2 Participants	8 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Breast development (for female) · Stage 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Breast development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Breast development (for female) · Stage 1	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Breast development (for female) · Stage 2	4 Participants	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Breast development (for female) · Stage 3	2 Participants	0 Participants	5 Participants	1 Participants	7 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Breast development (for female) · Stage 4	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Breast development (for female) · Stage 5	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for female) · Stage 1	6 Participants	1 Participants	1 Participants	0 Participants	7 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for female) · Stage 2	3 Participants	0 Participants	2 Participants	0 Participants	5 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for female) · Stage 3	0 Participants	1 Participants	3 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for female) · Stage 4	2 Participants	0 Participants	3 Participants	1 Participants	5 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for female) · Stage 1	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for female) · Stage 2	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for female) · Stage 3	4 Participants	1 Participants	2 Participants	1 Participants	6 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for female) · Stage 4	1 Participants	0 Participants	3 Participants	2 Participants	4 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for female) · Stage 5	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for male) · Stage 1	6 Participants	3 Participants	0 Participants	0 Participants	6 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for male) · Stage 2	0 Participants	1 Participants	3 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for male) · Stage 3	0 Participants	1 Participants	2 Participants	4 Participants	2 Participants	5 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for male) · Stage 4	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Pubic hair development (for male) · Stage 5	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for male) · Stage 1	4 Participants	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for male) · Stage 2	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for male) · Stage 3	0 Participants	1 Participants	3 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for male) · Stage 4	0 Participants	1 Participants	3 Participants	3 Participants	3 Participants	4 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Pubic hair development (for male) · Stage 5	0 Participants	0 Participants	3 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Penis development (for male) · Stage 1	6 Participants	5 Participants	0 Participants	1 Participants	6 Participants	6 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Penis development (for male) · Stage 2	0 Participants	0 Participants	4 Participants	3 Participants	4 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Penis development (for male) · Stage 3	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 0: Penis development (for male) · Stage 5	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Penis development (for male) · Stage 1	3 Participants	2 Participants	0 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Penis development (for male) · Stage 2	2 Participants	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Penis development (for male) · Stage 3	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Penis development (for male) · Stage 4	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Pubertal Status From Baseline at Week 52 Week 52: Penis development (for male) · Stage 5	0 Participants	0 Participants	3 Participants	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Change in Physical Examination From Baseline at Week 16 General Appearance: Week 0 · Abnormal, CS	2 Participants	1 Participants	4 Participants	1 Participants	6 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 General Appearance: Week 16 · Abnormal, CS	0 Participants	1 Participants	4 Participants	1 Participants	4 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 GI system including mouth: Week 0 · Normal	17 Participants	7 Participants	19 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Thyroid gland: Week 0 · Normal	17 Participants	7 Participants	20 Participants	12 Participants	37 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Thyroid gland: Week 0 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 General Appearance: Week 0 · Normal	12 Participants	5 Participants	14 Participants	10 Participants	26 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 General Appearance: Week 0 · Abnormal, NCS	3 Participants	1 Participants	2 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 General Appearance: Week 16 · Normal	11 Participants	5 Participants	14 Participants	11 Participants	25 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 General Appearance: Week 16 · Abnormal, NCS	4 Participants	1 Participants	1 Participants	0 Participants	5 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Head, ears, eyes, nose, throat, neck: Week 0 · Normal	15 Participants	6 Participants	19 Participants	10 Participants	34 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Head, ears, eyes, nose, throat, neck: Week 0 · Abnormal, NCS	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Head, ears, eyes, nose, throat, neck: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Head, ears, eyes, nose, throat, neck: Week 16 · Normal	15 Participants	7 Participants	18 Participants	12 Participants	33 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Head, ears, eyes, nose, throat, neck: Week 16 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Head, ears, eyes, nose, throat, neck: Week 16 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Respiratory system: Week 0 · Normal	16 Participants	7 Participants	20 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Respiratory system: Week 0 · Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Respiratory system: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Respiratory system: Week 16 · Normal	15 Participants	7 Participants	19 Participants	12 Participants	34 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Respiratory system: Week 16 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Respiratory system: Week 16 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Lymph node palpation: Week 16 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Cardiovascular system: Week 0 · Normal	17 Participants	7 Participants	19 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Cardiovascular system: Week 0 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Cardiovascular system: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Cardiovascular system: Week 16 · Normal	15 Participants	7 Participants	18 Participants	12 Participants	33 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Cardiovascular system: Week 16 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Cardiovascular system: Week 16 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 GI system including mouth: Week 0 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 GI system including mouth: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 GI system including mouth: Week 16 · Normal	15 Participants	7 Participants	17 Participants	12 Participants	32 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 GI system including mouth: Week 16 · Abnormal, NCS	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 GI system including mouth: Week 16 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Musculoskeletal system: Week 0 · Normal	14 Participants	6 Participants	15 Participants	9 Participants	29 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Musculoskeletal system: Week 0 · Abnormal, NCS	3 Participants	1 Participants	3 Participants	2 Participants	6 Participants	3 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Musculoskeletal system: Week 0 · Abnormal, CS	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Musculoskeletal system: Week 16 · Normal	11 Participants	6 Participants	16 Participants	9 Participants	27 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Musculoskeletal system: Week 16 · Abnormal, NCS	4 Participants	1 Participants	2 Participants	1 Participants	6 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Musculoskeletal system: Week 16 · Abnormal, CS	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 CNS and PNS: Week 0 · Normal	15 Participants	6 Participants	16 Participants	10 Participants	31 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 CNS and PNS: Week 0 · Abnormal, NCS	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 CNS and PNS: Week 0 · Abnormal, CS	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 CNS and PNS: Week 16 · Normal	14 Participants	7 Participants	15 Participants	11 Participants	29 Participants	18 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 CNS and PNS: Week 16 · Abnormal, NCS	1 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 CNS and PNS: Week 16 · Abnormal, CS	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Skin: Week 0 · Normal	10 Participants	6 Participants	11 Participants	7 Participants	21 Participants	13 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Skin: Week 0 · Abnormal, NCS	6 Participants	1 Participants	6 Participants	4 Participants	12 Participants	5 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Skin: Week 0 · Abnormal, CS	1 Participants	0 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Skin: Week 16 · Normal	10 Participants	6 Participants	12 Participants	8 Participants	22 Participants	14 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Skin: Week 16 · Abnormal, NCS	5 Participants	0 Participants	5 Participants	3 Participants	10 Participants	3 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Skin: Week 16 · Abnormal, CS	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Thyroid gland: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Thyroid gland: Week 16 · Normal	15 Participants	7 Participants	19 Participants	12 Participants	34 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Thyroid gland: Week 16 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Thyroid gland: Week 16 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Lymph node palpation: Week 0 · Normal	17 Participants	7 Participants	19 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Lymph node palpation: Week 0 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Lymph node palpation: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Lymph node palpation: Week 16 · Normal	15 Participants	7 Participants	19 Participants	12 Participants	34 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 16 Lymph node palpation: Week 16 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.

Outcome measures

Measure	Part B: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=37 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Number of Participants With Change in Physical Examination From Baseline at Week 52 General Appearance: Week 0 · Abnormal, NCS	3 Participants	1 Participants	2 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 General Appearance: Week 0 · Abnormal, CS	2 Participants	1 Participants	4 Participants	1 Participants	6 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 General Appearance: Week 52 · Abnormal, NCS	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Head, ears, eyes, nose, throat, neck: Week 0 · Abnormal, NCS	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 GI system including mouth: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Musculoskeletal system: Week 0 · Normal	14 Participants	6 Participants	15 Participants	9 Participants	29 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Musculoskeletal system: Week 52 · Abnormal, NCS	2 Participants	0 Participants	1 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 General Appearance: Week 52 · Abnormal, CS	1 Participants	0 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Head, ears, eyes, nose, throat, neck: Week 0 · Normal	15 Participants	6 Participants	19 Participants	10 Participants	34 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 General Appearance: Week 0 · Normal	12 Participants	5 Participants	14 Participants	10 Participants	26 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 General Appearance: Week 52 · Normal	9 Participants	5 Participants	13 Participants	10 Participants	22 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Head, ears, eyes, nose, throat, neck: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Head, ears, eyes, nose, throat, neck: Week 52 · Normal	12 Participants	4 Participants	15 Participants	11 Participants	27 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Head, ears, eyes, nose, throat, neck: Week 52 · Abnormal, NCS	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Head, ears, eyes, nose, throat, neck: Week 52 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Musculoskeletal system: Week 52 · Normal	10 Participants	5 Participants	15 Participants	10 Participants	25 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Respiratory system: Week 0 · Normal	16 Participants	7 Participants	20 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Respiratory system: Week 0 · Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Respiratory system: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Cardiovascular system: Week 0 · Normal	17 Participants	7 Participants	19 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Cardiovascular system: Week 0 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Cardiovascular system: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Cardiovascular system: Week 52 · Normal	12 Participants	5 Participants	17 Participants	10 Participants	29 Participants	15 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Cardiovascular system: Week 52 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Cardiovascular system: Week 52 · Abnormal, CS	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 GI system including mouth: Week 0 · Normal	17 Participants	7 Participants	19 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 GI system including mouth: Week 0 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 GI system including mouth: Week 52 · Normal	12 Participants	5 Participants	16 Participants	11 Participants	28 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 GI system including mouth: Week 52 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 GI system including mouth: Week 52 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Musculoskeletal system: Week 0 · Abnormal, NCS	3 Participants	1 Participants	3 Participants	2 Participants	6 Participants	3 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Musculoskeletal system: Week 0 · Abnormal, CS	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Musculoskeletal system: Week 52 · Abnormal, CS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 CNS and PNS: Week 0 · Normal	15 Participants	6 Participants	16 Participants	10 Participants	31 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 CNS and PNS: Week 0 · Abnormal, NCS	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 CNS and PNS: Week 0 · Abnormal, CS	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 CNS and PNS: Week 52 · Normal	11 Participants	4 Participants	13 Participants	10 Participants	24 Participants	14 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 CNS and PNS: Week 52 · Abnormal, NCS	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 CNS and PNS: Week 52 · Abnormal, CS	1 Participants	0 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Skin: Week 0 · Normal	10 Participants	6 Participants	11 Participants	7 Participants	21 Participants	13 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Skin: Week 0 · Abnormal, NCS	6 Participants	1 Participants	6 Participants	4 Participants	12 Participants	5 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Skin: Week 0 · Abnormal, CS	1 Participants	0 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Skin: Week 52 · Normal	9 Participants	4 Participants	13 Participants	8 Participants	22 Participants	12 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Skin: Week 52 · Abnormal, NCS	3 Participants	0 Participants	3 Participants	2 Participants	6 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Skin: Week 52 · Abnormal, CS	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Thyroid gland: Week 0 · Normal	17 Participants	7 Participants	20 Participants	12 Participants	37 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Thyroid gland: Week 0 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Thyroid gland: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Thyroid gland: Week 52 · Normal	12 Participants	5 Participants	17 Participants	11 Participants	29 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Thyroid gland: Week 52 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Thyroid gland: Week 52 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Lymph node palpation: Week 0 · Normal	17 Participants	7 Participants	19 Participants	12 Participants	36 Participants	19 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Lymph node palpation: Week 0 · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Lymph node palpation: Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Lymph node palpation: Week 52 · Normal	12 Participants	5 Participants	17 Participants	11 Participants	29 Participants	16 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Lymph node palpation: Week 52 · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Change in Physical Examination From Baseline at Week 52 Lymph node palpation: Week 52 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented.

Outcome measures

Measure	Part B: Liraglutide n=16 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=7 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=34 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=19 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Height Velocity at Week 16	4.190 Centimeters/year (cm/yr) Standard Deviation 2.604	6.898 Centimeters/year (cm/yr) Standard Deviation 2.886	2.113 Centimeters/year (cm/yr) Standard Deviation 3.084	2.718 Centimeters/year (cm/yr) Standard Deviation 4.281	3.090 Centimeters/year (cm/yr) Standard Deviation 3.014	4.258 Centimeters/year (cm/yr) Standard Deviation 4.274

SECONDARY outcome

Timeframe: week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented.

Outcome measures

Measure	Part B: Liraglutide n=14 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo n=6 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=17 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide n=31 Participants Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo n=17 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Height Velocity at Week 52	4.752 Centimeters/year (cm/yr) Standard Deviation 2.250	5.620 Centimeters/year (cm/yr) Standard Deviation 1.690	1.564 Centimeters/year (cm/yr) Standard Deviation 1.285	1.839 Centimeters/year (cm/yr) Standard Deviation 1.658	3.004 Centimeters/year (cm/yr) Standard Deviation 2.383	3.173 Centimeters/year (cm/yr) Standard Deviation 2.466

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. This outcome measure was planned to be analyzed for Part A only.

C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B.

Outcome measures

Measure	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 Week 0: Suicidal ideation	—	—	1 Participants	3 Participants	—	—
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 Week 0: Suicidal behaviour	—	—	0 Participants	0 Participants	—	—
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 Week 16: Suicidal ideation	—	—	1 Participants	1 Participants	—	—
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 Week 16: Suicidal behaviour	—	—	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. This outcome measure was planned to be analyzed for Part A only.

C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B.

Outcome measures

Measure	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=20 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 Week 0: Suicidal ideation	—	—	1 Participants	3 Participants	—	—
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 Week 0: Suicidal behaviour	—	—	0 Participants	0 Participants	—	—
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 Week 52: Suicidal ideation	—	—	1 Participants	0 Participants	—	—
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 Week 52: Suicidal behaviour	—	—	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 0, week 16

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. This outcome measure was planned to be analyzed for Part A only.

Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.

Outcome measures

Measure	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=19 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=12 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16	—	—	-2 Score on a scale Standard Deviation 4	1 Score on a scale Standard Deviation 5	—	—

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. This outcome measure was planned to be analyzed for Part A only.

Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.

Outcome measures

Measure	Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A: Liraglutide n=18 Participants Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part A: Placebo n=11 Participants Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part A+B: Liraglutide Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight \< 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A+B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52	—	—	-2 Score on a scale Standard Deviation 3	0 Score on a scale Standard Deviation 3	—	—

Adverse Events

Part A: Liraglutide

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B: Liraglutide

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Part A: Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Liraglutide n=20 participants at risk Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part B: Liraglutide n=17 participants at risk Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A: Placebo n=12 participants at risk Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part B: Placebo n=7 participants at risk Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Surgical and medical procedures Arthrodesis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Hepatobiliary disorders Cholelithiasis	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Hyperthermia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	14.3% 1/7 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Surgical and medical procedures Spinal operation	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Staphylococcal infection	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).

Other adverse events

Measure	Part A: Liraglutide n=20 participants at risk Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Part B: Liraglutide n=17 participants at risk Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Part A: Placebo n=12 participants at risk Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Part B: Placebo n=7 participants at risk Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Abdominal injury	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Abdominal pain	30.0% 6/20 • Number of events 8 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	17.6% 3/17 • Number of events 12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	25.0% 3/12 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Abdominal pain upper	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	17.6% 3/17 • Number of events 7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Abdominal rigidity	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Acarodermatitis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Aggression	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Reproductive system and breast disorders Amenorrhoea	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Amylase increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Arthropod bite	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Asthenia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Behaviour disorder	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Blood calcitonin increased	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Blood creatine phosphokinase increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Blood insulin increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Blood thyroid stimulating hormone increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Bronchitis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations C-reactive protein increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Chest pain	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Conjunctivitis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Constipation	15.0% 3/20 • Number of events 4 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Respiratory, thoracic and mediastinal disorders Cough	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Dental caries	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Depression	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Diarrhoea	50.0% 10/20 • Number of events 30 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	41.2% 7/17 • Number of events 62 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	16.7% 2/12 • Number of events 4 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Renal and urinary disorders Dysuria	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Ear infection viral	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Ear and labyrinth disorders Ear pain	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Surgical and medical procedures Ear tube insertion	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Fall	5.0% 1/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Fatigue	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Flatulence	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Fungal infection	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Gastroenteritis	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 4 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Gastrointestinal viral infection	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Gastrooesophageal reflux disease	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Glycosylated haemoglobin increased	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Hallucination, auditory	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Nervous system disorders Headache	10.0% 2/20 • Number of events 8 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	25.0% 3/12 • Number of events 6 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Hepatobiliary disorders Hepatocellular injury	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Metabolism and nutrition disorders Hypercholesterolaemia	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Endocrine disorders Hypothyroidism	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Endocrine disorders Immune-mediated thyroiditis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Impetigo	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Influenza	10.0% 2/20 • Number of events 4 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	28.6% 2/7 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Injection site bruising	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Injection site haematoma	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Injection site haemorrhage	5.0% 1/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Injection site nodule	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Insomnia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Metabolism and nutrition disorders Insulin resistance	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Insulin-like growth factor decreased	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Musculoskeletal and connective tissue disorders Knee deformity	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Limb injury	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Low density lipoprotein increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Lower respiratory tract infection	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Malaise	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	16.7% 2/12 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Nasopharyngitis	15.0% 3/20 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 5 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Oral herpes	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 2/20 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	14.3% 1/7 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Otitis media	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Overflow diarrhoea	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Surgical and medical procedures Pain prophylaxis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Nervous system disorders Paraesthesia	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Peripheral swelling	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Pharyngitis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Endocrine disorders Precocious puberty	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
General disorders Pyrexia	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	14.3% 1/7 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Respiratory tract infection viral	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Rhinitis	10.0% 2/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Immune system disorders Seasonal allergy	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Sinusitis	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Skin infection	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Skin and subcutaneous tissue disorders Skin mass	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	14.3% 1/7 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Sleep disorder	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Soft tissue injury	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Thyroxine free decreased	10.0% 2/20 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Psychiatric disorders Tic	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Tinea versicolour	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Tonsillitis	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Surgical and medical procedures Tooth extraction	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Upper respiratory tract infection	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	11.8% 2/17 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	14.3% 1/7 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Urinary tract infection	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	5.9% 1/17 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Ear and labyrinth disorders Vertigo	0.00% 0/20 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	8.3% 1/12 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Viral infection	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Infections and infestations Viral upper respiratory tract infection	5.0% 1/20 • Number of events 2 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Metabolism and nutrition disorders Vitamin D deficiency	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Gastrointestinal disorders Vomiting	10.0% 2/20 • Number of events 3 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	17.6% 3/17 • Number of events 4 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Investigations Weight increased	5.0% 1/20 • Number of events 1 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/17 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/12 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).	0.00% 0/7 • From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period. On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).

Additional Information

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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.
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