Trial Outcomes & Findings for Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A (NCT NCT01480180)

Last Updated: 2020-11-23

Results Overview

All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

186 participants

Primary outcome timeframe

After approximately 19 months

Results posted on

2020-11-23

Participant Flow

The trial was conducted at 77 sites in 22 countries as follows: Australia:3; Brazil:1; Croatia:1; Denmark:2; France:3; Germany:5; Hungary:2; Israel:1; Italy:2; Japan:8; Malaysia:2; Netherlands:2; Norway:1; Russian Federation:1; Korea, Republic of:1; Spain:2; Sweden:1; Switzerland:3; Taiwan:2; Turkey:3; United Kingdom:6; United States:25.

The trial had a main phase and an extension phase 1 and phase 2.

Participant milestones

Participant milestones
Measure	Prophylaxis Participants received one single bolus dose of 50 U/kg of body weight (BW) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm. This arm is applicable only for the main phase.	On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5. This arm is applicable only for the main phase.	N8-GP 50 U/kg Prophylaxis Q4D Participants who were on prophylaxis treatment with N8-GP in the main phase and had 0-2 bleeding episodes during the last 6 months before entering the extension phase, were included in this arm. Participants received one single bolus dose of 50 U/kg BW of N8-GP administered IV every 4th day (96 hours) or twice weekly (at investigator's discretion). The dose was adjusted to ensure a trough level of \>1% FVIII:C activity in this arm. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm. This arm was applicable for the extension phase part-1 and part 2.	N8-GP 75 U/kg Prophylaxis Q7D Participants who were on prophylaxis treatment with N8-GP in the main phase and had 3+ bleeding episodes during the last 6 months before entering the extension phase, were randomised to receive one single bolus dose of 75 U/kg BW of N8-GP. Participants received one single bolus dose of 75 U/kg BW of N8-GP administered IV every 7th day (Q7D). Based on the bleeding pattern, the investigator could change the dosing frequency from Q7D to Q4D, but not vice versa. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Main Phase STARTED	174	12	0	0	0
Main Phase Max. Participants After Switching	175	11	0	0	0
Main Phase COMPLETED	155	11	0	0	0
Main Phase NOT COMPLETED	19	1	0	0	0
Extension Phase, Part 1 STARTED	0	0	105	38	7
Extension Phase, Part 1 COMPLETED	0	0	95	28	7
Extension Phase, Part 1 NOT COMPLETED	0	0	10	10	0
Extension Phase, Part 2 STARTED	0	0	94	40	5
Extension Phase, Part 2 COMPLETED	0	0	77	33	3
Extension Phase, Part 2 NOT COMPLETED	0	0	17	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Prophylaxis Participants received one single bolus dose of 50 U/kg of body weight (BW) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm. This arm is applicable only for the main phase.	On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5. This arm is applicable only for the main phase.	N8-GP 50 U/kg Prophylaxis Q4D Participants who were on prophylaxis treatment with N8-GP in the main phase and had 0-2 bleeding episodes during the last 6 months before entering the extension phase, were included in this arm. Participants received one single bolus dose of 50 U/kg BW of N8-GP administered IV every 4th day (96 hours) or twice weekly (at investigator's discretion). The dose was adjusted to ensure a trough level of \>1% FVIII:C activity in this arm. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm. This arm was applicable for the extension phase part-1 and part 2.	N8-GP 75 U/kg Prophylaxis Q7D Participants who were on prophylaxis treatment with N8-GP in the main phase and had 3+ bleeding episodes during the last 6 months before entering the extension phase, were randomised to receive one single bolus dose of 75 U/kg BW of N8-GP. Participants received one single bolus dose of 75 U/kg BW of N8-GP administered IV every 7th day (Q7D). Based on the bleeding pattern, the investigator could change the dosing frequency from Q7D to Q4D, but not vice versa. The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Main Phase Withdrawal criteria	12	1	0	0	0
Main Phase Lack of Efficacy	1	0	0	0	0
Main Phase Non-compliance	3	0	0	0	0
Main Phase Unclassified	3	0	0	0	0
Extension Phase, Part 1 Withdrawal criteria	0	0	5	0	0
Extension Phase, Part 1 Unclassified	0	0	1	0	0
Extension Phase, Part 1 Adverse Event	0	0	4	1	0
Extension Phase, Part 1 Change of treatment	0	0	0	9	0
Extension Phase, Part 2 Withdrawal criteria	0	0	10	6	1
Extension Phase, Part 2 Lack of Efficacy	0	0	4	0	0
Extension Phase, Part 2 Unclassified	0	0	3	1	1

Baseline Characteristics

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prophylaxis n=174 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	Total n=186 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 12.4 • n=93 Participants	39.8 years STANDARD_DEVIATION 13.9 • n=4 Participants	31.1 years STANDARD_DEVIATION 12.6 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	174 Participants n=93 Participants	12 Participants n=4 Participants	186 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	13 Participants n=93 Participants	0 Participants n=4 Participants	13 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	161 Participants n=93 Participants	12 Participants n=4 Participants	173 Participants n=27 Participants
Race/Ethnicity, Customized Asian	31 Participants n=93 Participants	4 Participants n=4 Participants	35 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=93 Participants	3 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized White	133 Participants n=93 Participants	5 Participants n=4 Participants	138 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: After approximately 19 months

Population: Results are based on the safety analysis set (SAS). SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months	0.006 Inhibitor rate	0 Inhibitor rate	—

PRIMARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the full analysis set (FAS) which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Annualised bleeding rate (ABR) is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months	1.33 Bleeds per participant per year Interval 0.0 to 4.61	—	—

PRIMARY outcome

Timeframe: After approximately 25 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months	0.006 Inhibitor rate	0 Inhibitor rate	0 Inhibitor rate

PRIMARY outcome

Timeframe: After approximately 25 months

Population: Results are based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

ABR is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months	1.36 Bleeds per participant per year Interval 0.0 to 4.0	0 Bleeds per participant per year Interval 0.0 to 2.36	—

PRIMARY outcome

Timeframe: At approximately 80 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months	0.006 Inhibitor rate	0 Inhibitor rate	—

PRIMARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Annualised bleeding rate (ABR) is the number of bleeding episodes per year reported during the prophylactic treatment with N8-GP.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months	0.99 Bleeds per participant per year Interval 0.0 to 2.68	1.95 Bleeds per participant per year Interval 0.43 to 6.52	—

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.

Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=436 Bleeding episodes Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=532 Bleeding episodes Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months Excellent	192 Bleeding episodes	320 Bleeding episodes	—
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months Good	174 Bleeding episodes	170 Bleeding episodes	—
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months Moderate	62 Bleeding episodes	41 Bleeding episodes	—
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months None	4 Bleeding episodes	1 Bleeding episodes	—
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months Missing	4 Bleeding episodes	0 Bleeding episodes	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=716 Bleeding episodes Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=25 Bleeding episodes Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=695 Bleeding episodes Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months Excellent	330 Bleeding episodes	9 Bleeding episodes	406 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months Good	270 Bleeding episodes	11 Bleeding episodes	233 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months Moderate	98 Bleeding episodes	3 Bleeding episodes	55 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months None	4 Bleeding episodes	0 Bleeding episodes	1 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months Missing	14 Bleeding episodes	2 Bleeding episodes	0 Bleeding episodes

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=1312 Bleeding episodes Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=176 Bleeding episodes Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=1270 Bleeding episodes Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months Excellent	600 Bleeding episodes	75 Bleeding episodes	859 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months Good	532 Bleeding episodes	65 Bleeding episodes	339 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months Moderate	153 Bleeding episodes	29 Bleeding episodes	71 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months None	6 Bleeding episodes	2 Bleeding episodes	1 Bleeding episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months Missing	21 Bleeding episodes	5 Bleeding episodes	0 Bleeding episodes

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm.

The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=436 Infusions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=532 Infusions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months	1.4 Number of infusions Standard Deviation 1.0	1.2 Number of infusions Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm.

The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=716 Infusions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=25 Infusions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=695 Infusions Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 25 Months	1.4 Number of infusions Standard Deviation 1.3	1.3 Number of infusions Standard Deviation 0.6	1.2 Number of infusions Standard Deviation 0.8

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm.

The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=1312 Infusions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=176 Infusions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=1270 Infusions Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 80 Months	1.4 Number of infusions Standard Deviation 1.3	1.3 Number of infusions Standard Deviation 0.6	1.2 Number of infusions Standard Deviation 0.8

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed

The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=436 Bleeding episodes Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=532 Bleeding episodes Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 19 Months	64.6 U/kg per bleed Standard Deviation 48.8	41.0 U/kg per bleed Standard Deviation 35.1	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.

The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=716 Bleeding episodes Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=25 Bleeding episodes Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=695 Bleeding episodes Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 25 Months	67.8 U/kg per bleed Standard Deviation 72.9	78.2 U/kg per bleed Standard Deviation 37.8	39.3 U/kg per bleed Standard Deviation 32.4

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.

The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=175 Bleeding episodes Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=1270 Bleeding episodes Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 80 Months	68.1 U/kg per bleed Standard Deviation 60.0	88.7 U/kg per bleed Standard Deviation 72.4	37.5 U/kg per bleed Standard Deviation 38.0

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions used during prophylaxis and on-demand treatment.

Number of infusions are presented as average dose used during propphylaxis and on-demand treatment.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=436 Infusions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=532 Infusions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 19 Months	52.2 U/kg Standard Deviation 1.4	46.3 U/kg Standard Deviation 10.4	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions used during prophylaxis and on-demand treatment.

Number of infusions are presented as average dose used during prophylaxis and on-demand treatment.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=22569 Infusions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=775 Infusions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=35 Infusions Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 25 Months	52.2 U/kg Standard Deviation 1.9	77.2 U/kg Standard Deviation 3.2	44.8 U/kg Standard Deviation 11.4

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions used during prophylaxis and on-demand treatment.

Number of infusions are presented as average dose used during prophylaxis and on-demand treatment.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=55896 Infusions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=6996 Infusions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=58 Infusions Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 80 Months	52.2 U/kg Standard Deviation 1.5	77.1 U/kg Standard Deviation 3.2	37.5 U/kg Standard Deviation 13.0

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 19 Months	403.8 U/kg per month Standard Deviation 53.8	129.2 U/kg per month Standard Deviation 71.8	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 25 Months	403.8 U/kg per month Standard Deviation 53.8	349.2 U/kg per month Standard Deviation 37.9	128.2 U/kg per month Standard Deviation 70.1

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 80 Months	402.4 U/kg per month Standard Deviation 52.4	353.5 U/kg per month Standard Deviation 32.9	130.2 U/kg per month Standard Deviation 69.2

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 19 Months	4845 U/kg per year Standard Deviation 645	1550 U/kg per year Standard Deviation 861	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 25 Months	4846 U/kg per year Standard Deviation 645.3	4190 U/kg per year Standard Deviation 454.5	1538 U/kg per year Standard Deviation 840.6

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 80 Months	4829 U/kg per year Standard Deviation 628.8	4242 U/kg per year Standard Deviation 394.5	1562 U/kg per year Standard Deviation 830.3

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Recovery and trough levels of FVIII:C was reported for all participants at Visit 3 (Week 4) and end of main phase (approx. 19 months). The data was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N8-GP product specific standard (PSS) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months Visit 2 Post-dose	1.276 U/mL Geometric Coefficient of Variation 18.584	—	—
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months Visit 3 Pre-dose	0.030 U/mL Geometric Coefficient of Variation 159.920	—	—
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months Visit 12 Post-dose	1.359 U/mL Geometric Coefficient of Variation 18.156	—	—
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months Visit 13 Pre-dose	0.034 U/mL Geometric Coefficient of Variation 188.891	—	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Recovery and trough levels of FVIII:C was reported for all participants at the end of extension phase 1 study (approx. 25 months). The data was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N8-GP product specific standard (PSS) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 25 Months Visit 16 Post-dose	1.329 U/mL Geometric Coefficient of Variation 13.357	1.868 U/mL Geometric Coefficient of Variation 31.919	—
Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 25 Months Visit 17 Pre-dose	0.028 U/mL Geometric Coefficient of Variation 205.652	0.015 U/mL Geometric Coefficient of Variation 272.494	—

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Data were not collected for this endpoint.

Since patients were allowed to change prophylaxis regimen at any time during the extension phase part 2, and since the visit intervals were different for the 2 prophylaxis treatment regimens (Q4D and Q7D), FVIII activity data are reported only as incremental recovery at this timepoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data. No participants from the 13-16 years age group received on-demand treatment. Thus on-demand treatment group is not applicable for this endpoint.

Reported results are change from baseline (Month 0) measured at end of main phase (approx Month 19) and change from Month 19 at end of Extension 1 (approx Month 25) of the study. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=16 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old) After Approx 19 and 25 Months Approx month 19 (Change from baseline)	-0.1 Scores on a scale Standard Deviation 12.4	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old) After Approx 19 and 25 Months Approx month 25 (Change from month 19)	0.8 Scores on a scale Standard Deviation 4.5	—	—

SECONDARY outcome

Timeframe: 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. No participants from the 13-16 years age group received on-demand treatment. Thus on-demand treatment group is not applicable for this endpoint.

Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=11 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months 2 to <3 years (Change from baseline)	2.7 Scores on a scale Standard Deviation 15.9	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months 3 to <4 years (Change from baseline)	-0.9 Scores on a scale Standard Deviation 11.6	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months 4 to <5 years (Change from baseline)	2.6 Scores on a scale Standard Deviation 15.8	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months 5 to <6 years (Change from baseline)	2.1 Scores on a scale Standard Deviation 11.7	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months 6 to <7 years (Change from baseline)	-0.3 Scores on a scale Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The questionnaire was completed by parents of the patients in the 13-16 years old age bracket. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=16 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 19 and 25 Months After approximately 19 months	-4.0 Scores on a scale Standard Deviation 13.1	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 19 and 25 Months After approximately 25 months	1.8 Scores on a scale Standard Deviation 8.3	—	—

SECONDARY outcome

Timeframe: 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. The questionnaire was completed by parents of the patients in the 13-16 years old age bracket. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=8 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months 2 to <3 years (Change from baseline)	1.5 Scores on a scale Standard Deviation 2.1	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months 3 to <4 years (Change from baseline)	-8.1 Scores on a scale Standard Deviation 7.0	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months 4 to <5 years (Change from baseline)	-7.9 Scores on a scale Standard Deviation 13.8	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months 5 to <6 years (Change from baseline)	1.6 Scores on a scale Standard Deviation 11.4	—	—
Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months 6 to <7 years (Change from baseline)	10.7 Scores on a scale Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The HAEM-A-QOL (for adults (\>=17 years)) assessment included questions on questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=157 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approx 19 and 25 Months Week 76 (Change from baseline)	-2.3 Scores on a scale Standard Deviation 8.9	-3.1 Scores on a scale Standard Deviation 10.3	—
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approx 19 and 25 Months Week 140 (Change from week 76)	0.7 Scores on a scale Standard Deviation 8.0	-0.6 Scores on a scale Standard Deviation 4.9	—

SECONDARY outcome

Timeframe: 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The HAEM-A-QOL (for adults (\>=17 years)) assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=157 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=5 Number of questionnaires Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months 1 to <2 years (Change from baseline)	-6.6 Scores on a scale Standard Deviation 6.7	—	—
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months 2 to <3 years (Change from baseline)	-2.6 Scores on a scale Standard Deviation 10.3	-10.7 Scores on a scale Standard Deviation 8.7	—
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months 3 to <4 years (Change from baseline)	-2.3 Scores on a scale Standard Deviation 8.9	-5.8 Scores on a scale Standard Deviation 12.2	—
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months 4 to <5 years (Change from baseline)	-3.1 Scores on a scale Standard Deviation 10.4	-2.5 Scores on a scale Standard Deviation 19.5	—
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months 5 to <6 years (Change from baseline)	-3.1 Scores on a scale Standard Deviation 11.2	-1.7 Scores on a scale Standard Deviation 2.8	—
Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months 6 to <7 years (Change from baseline)	-3.5 Scores on a scale Standard Deviation 9.0	-7.8 Scores on a scale Standard Deviation 8.6	—

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The HEMO-SAT (Hematology-satisfaction) assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by patients). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=157 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Ease & convenience (Change - Approx 19 months)	-0.4 Scores on a scale Standard Deviation 13.8	-4.5 Scores on a scale Standard Deviation 11.5	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Ease & convenience (Change - Approx 25 months)	0.3 Scores on a scale Standard Deviation 11.7	-6.3 Scores on a scale Standard Deviation 6.9	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Efficacy (Change - Approx 19 months)	-6.3 Scores on a scale Standard Deviation 15.6	-11.3 Scores on a scale Standard Deviation 11.1	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Efficacy (Change - Approx 25 months)	-0.2 Scores on a scale Standard Deviation 11.0	0.0 Scores on a scale Standard Deviation 5.9	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Burden (Change - Approx 19 months)	-2.2 Scores on a scale Standard Deviation 15.8	-5.0 Scores on a scale Standard Deviation 18.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Burden (Change - Approx 25 months)	-0.9 Scores on a scale Standard Deviation 11.3	0.0 Scores on a scale Standard Deviation 6.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Speciaist/nurses (Change - approx 19 months)	-2.9 Scores on a scale Standard Deviation 11.7	-4.5 Scores on a scale Standard Deviation 8.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Speciaist/nurses (Change - approx 25 months)	1.8 Scores on a scale Standard Deviation 9.1	0.0 Scores on a scale Standard Deviation 8.1	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Centre/hospital (Change - approx 19 months)	-2.2 Scores on a scale Standard Deviation 11.9	-3.6 Scores on a scale Standard Deviation 7.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Centre/hospital (Change - approx 25 months)	1.0 Scores on a scale Standard Deviation 8.1	4.2 Scores on a scale Standard Deviation 10.7	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Gen. satisfaction (Change - approx 19 months)	-2.9 Scores on a scale Standard Deviation 15.4	-3.4 Scores on a scale Standard Deviation 11.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months Gen. satisfaction (Change - approx 25 months)	-1.1 Scores on a scale Standard Deviation 9.4	2.1 Scores on a scale Standard Deviation 5.1	—

SECONDARY outcome

Timeframe: 1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.

Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by patients). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=151 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=5 Number of questionnaires Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Ease & convenience 1 to <2 years	-2.2 Scores on a scale Standard Deviation 12.7	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Ease & convenience 2 to <3 years	-2.4 Scores on a scale Standard Deviation 14.4	-23.8 Scores on a scale Standard Deviation 12.4	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Ease & convenience 3 to <4 years	-3.7 Scores on a scale Standard Deviation 13.6	-10.5 Scores on a scale Standard Deviation 18.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Ease & convenience 4 to <5 years	-3.7 Scores on a scale Standard Deviation 13.6	-4.4 Scores on a scale Standard Deviation 34.4	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Ease & convenience 5 to <6 years	-3.3 Scores on a scale Standard Deviation 13.7	-16.7 Scores on a scale Standard Deviation 11.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Ease & convenience 6 to <7 years	-7.2 Scores on a scale Standard Deviation 12.4	-5.6 Scores on a scale Standard Deviation 8.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Efficacy 1 to <2 years	-1.9 Scores on a scale Standard Deviation 9.3	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Efficacy 2 to <3 years	-7.1 Scores on a scale Standard Deviation 14.9	-16.7 Scores on a scale Standard Deviation 5.9	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Efficacy 3 to <4 years	-7.2 Scores on a scale Standard Deviation 13.6	-17.5 Scores on a scale Standard Deviation 14.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Efficacy 4 to <5 years	-9.5 Scores on a scale Standard Deviation 16.4	2.1 Scores on a scale Standard Deviation 35.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Efficacy 5 to <6 years	-7.4 Scores on a scale Standard Deviation 14.4	-16.7 Scores on a scale Standard Deviation 20.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Efficacy 6 to <7 years	-13.2 Scores on a scale Standard Deviation 21.8	-3.1 Scores on a scale Standard Deviation 13.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Burden 1 to <2 years	0.7 Scores on a scale Standard Deviation 13.4	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Burden 2 to <3 years	-3.6 Scores on a scale Standard Deviation 16.9	-21.9 Scores on a scale Standard Deviation 4.4	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Burden 3 to <4 years	-5.0 Scores on a scale Standard Deviation 15.1	-17.5 Scores on a scale Standard Deviation 14.9	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Burden 4 to <5 years	-4.9 Scores on a scale Standard Deviation 16.9	-3.1 Scores on a scale Standard Deviation 28.2	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Burden 5 to <6 years	-4.9 Scores on a scale Standard Deviation 13.5	-18.8 Scores on a scale Standard Deviation 10.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Burden 6 to <7 years	-10.1 Scores on a scale Standard Deviation 19.1	-4.7 Scores on a scale Standard Deviation 9.4	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Specialist/nurses 1 to <2 years	-2.0 Scores on a scale Standard Deviation 12.8	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Specialist/nurses 2 to <3 years	-2.8 Scores on a scale Standard Deviation 11.4	0.0 Scores on a scale Standard Deviation 0.0	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Specialist/nurses 3 to <4 years	-2.3 Scores on a scale Standard Deviation 10.9	0.7 Scores on a scale Standard Deviation 8.9	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Specialist/nurses 4 to <5 years	-1.4 Scores on a scale Standard Deviation 11.4	21.4 Scores on a scale Standard Deviation 47.7	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Specialist/nurses 5 to <6 years	-0.8 Scores on a scale Standard Deviation 9.7	-11.9 Scores on a scale Standard Deviation 8.2	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Specialist/nurses 6 to <7 years	-0.2 Scores on a scale Standard Deviation 15.4	-6.3 Scores on a scale Standard Deviation 7.4	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Centre/hospital 1 to <2 years	-5.0 Scores on a scale Standard Deviation 12.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Centre/hospital 2 to <3 years	-2.9 Scores on a scale Standard Deviation 11.9	0.0 Scores on a scale Standard Deviation 0.0	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Centre/hospital 3 to <4 years	-1.3 Scores on a scale Standard Deviation 10.5	3.0 Scores on a scale Standard Deviation 4.5	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Centre/hospital 4 to <5 years	-1.1 Scores on a scale Standard Deviation 12.5	26.3 Scores on a scale Standard Deviation 43.1	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Centre/hospital 5 to <6 years	-1.0 Scores on a scale Standard Deviation 9.7	1.7 Scores on a scale Standard Deviation 29.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Centre/hospital 6 to <7 years	1.2 Scores on a scale Standard Deviation 17.7	-8.8 Scores on a scale Standard Deviation 6.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Gen. satisfaction 1 to <2 years	-1.4 Scores on a scale Standard Deviation 11.6	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Gen. satisfaction 2 to <3 years	-4.1 Scores on a scale Standard Deviation 15.2	-6.3 Scores on a scale Standard Deviation 8.8	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Gen. satisfaction 3 to <4 years	-2.8 Scores on a scale Standard Deviation 10.7	-17.5 Scores on a scale Standard Deviation 14.3	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Gen. satisfaction 4 to <5 years	-5.0 Scores on a scale Standard Deviation 14.4	0.0 Scores on a scale Standard Deviation 35.4	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Gen. satisfaction 5 to <6 years	-2.2 Scores on a scale Standard Deviation 12.2	-20.8 Scores on a scale Standard Deviation 7.2	—
Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months Gen. satisfaction 6 to <7 years	-5.4 Scores on a scale Standard Deviation 19.6	-18.8 Scores on a scale Standard Deviation 16.1	—

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0). The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by parents). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=16 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Ease & convenience - baseline (Week 0)	27.8 Scores on a scale Standard Deviation 15.5	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Ease & convenience (Change - Approx 19 months)	0.4 Scores on a scale Standard Deviation 3.3	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Ease & convenience (Change - Approx 25 months)	-6.3 Scores on a scale Standard Deviation 8.1	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Efficacy - baseline (Week 0)	17.9 Scores on a scale Standard Deviation 12.3	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Efficacy (Change - Approx 19 months)	-5.2 Scores on a scale Standard Deviation 2.1	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Efficacy (Change - Approx 25 months)	2.1 Scores on a scale Standard Deviation 5.7	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Burden- baseline (Week 0)	23.8 Scores on a scale Standard Deviation 14.4	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Burden (Change - Approx 19 months)	-10.9 Scores on a scale Standard Deviation 12.9	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Burden (Change - Approx 25 months)	-4.2 Scores on a scale Standard Deviation 11.6	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Specialist/nurses (Week 0)	7.1 Scores on a scale Standard Deviation 10.9	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Speciaist/nurses (Change - approx 19 months)	0.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Speciaist/nurses (Change - approx 25 months)	0.6 Scores on a scale Standard Deviation 1.5	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Centre/Hospital (Week 0)	10.5 Scores on a scale Standard Deviation 11.7	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Centre/hospital (Change - approx 19 months)	-3.7 Scores on a scale Standard Deviation 4.8	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Centre/hospital (Change - approx 25 months)	-0.8 Scores on a scale Standard Deviation 2.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Gen. satisfaction (Week 0)	8.8 Scores on a scale Standard Deviation 11.9	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Gen. satisfaction (Change - approx 19 months)	0.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months Gen. satisfaction (Change - approx 25 months)	0.0 Scores on a scale Standard Deviation 0.0	—	—

SECONDARY outcome

Timeframe: 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.

Reported results are from Visit 1 (Month 0), and change from visit 1 upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Max. no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = max. number of participants contributed to the analysis for each time point. The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction. Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=8 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Ease & convenience 2 to <3 years	-0.6 Scores on a scale Standard Deviation 6.8	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Ease & convenience 3 to <4 years	9.1 Scores on a scale Standard Deviation 0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Ease & convenience 4 to <5 years	-5.3 Scores on a scale Standard Deviation 14.1	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Ease & convenience 5 to <6 years	-3.6 Scores on a scale Standard Deviation 13.5	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Ease & convenience 6 to <7 years	0.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Efficacy 2 to <3 years	-6.3 Scores on a scale Standard Deviation 2.4	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Efficacy 3 to <4 years	-8.3 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Efficacy 4 to <5 years	-6.3 Scores on a scale Standard Deviation 4.4	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Efficacy 5 to <6 years	3.3 Scores on a scale Standard Deviation 17.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Efficacy 6 to <7 years	-4.2 Scores on a scale Standard Deviation 0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Burden 2 to <3 years	-20.3 Scores on a scale Standard Deviation 15.6	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Burden 3 to <4 years	-25.0 Scores on a scale Standard Deviation 0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Burden 4 to <5 years	-6.3 Scores on a scale Standard Deviation 26.2	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Burden 5 to <6 years	2.5 Scores on a scale Standard Deviation 15.1	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Burden 6 to <7 years	-31.3 Scores on a scale Standard Deviation 0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Specialist/nurses 2 to <3 years	-3.6 Scores on a scale Standard Deviation 7.1	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Specialist/nurses 3 to <4 years	0.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Specialist/nurses 4 to <5 years	-6.5 Scores on a scale Standard Deviation 11.8	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Specialist/nurses 5 to <6 years	3.6 Scores on a scale Standard Deviation 17.5	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Specialist/nurses 6 to <7 years	0.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Centre/hospital 2 to <3 years	-3.7 Scores on a scale Standard Deviation 4.8	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Centre/hospital 3 to <4 years	-5.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Centre/hospital 4 to <5 years	-8.3 Scores on a scale Standard Deviation 8.8	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Centre/hospital 5 to <6 years	-3.0 Scores on a scale Standard Deviation 14.4	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Centre/hospital 6 to <7 years	0.0 Scores on a scale Standard Deviation 0.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Gen. satisfaction 2 to <3 years	-9.4 Scores on a scale Standard Deviation 12.0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Gen. satisfaction 3 to <4 years	-12.5 Scores on a scale Standard Deviation 0	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Gen. satisfaction 4 to <5 years	-6.3 Scores on a scale Standard Deviation 10.5	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Gen. satisfaction 5 to <6 years	5.0 Scores on a scale Standard Deviation 14.3	—	—
Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months Gen. satisfaction 6 to <7 years	0.0 Scores on a scale Standard Deviation 0.0	—	—

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The European quality of life visual analogue scale (EQ5D-VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. A positive change indicates an improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=173 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approx 19 and 25 Months Week 0 (Baseline)	76.5 Scores on a scale Standard Deviation 17.9	74.5 Scores on a scale Standard Deviation 13.1	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approx 19 and 25 Months Week 76 (Change from baseline)	2.0 Scores on a scale Standard Deviation 11.1	4.1 Scores on a scale Standard Deviation 7.2	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approx 19 and 25 Months Week 140 (Change from week 76)	-0.8 Scores on a scale Standard Deviation 11.8	2.7 Scores on a scale Standard Deviation 11.0	—

SECONDARY outcome

Timeframe: 1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.

Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The EQ5D-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. A positive change indicates an improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=167 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=5 Number of questionnaires Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months 1 to <2 years (Change from baseline)	4.9 Scores on a scale Standard Deviation 8.2	—	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months 2 to <3 years (Change from baseline)	2.6 Scores on a scale Standard Deviation 13.3	9.5 Scores on a scale Standard Deviation 6.4	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months 3 to <4 years (Change from baseline)	3.0 Scores on a scale Standard Deviation 13.5	7.3 Scores on a scale Standard Deviation 7.0	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months 4 to <5 years (Change from baseline)	1.0 Scores on a scale Standard Deviation 15.8	11.0 Scores on a scale Standard Deviation 9.6	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months 5 to <6 years (Change from baseline)	2.2 Scores on a scale Standard Deviation 13.2	15.0 Scores on a scale Standard Deviation 21.2	—
Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months 6 to <7 years (Change from baseline)	7.5 Scores on a scale Standard Deviation 13.6	16.3 Scores on a scale Standard Deviation 12.1	—

SECONDARY outcome

Timeframe: After approx 19 and 25 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The European quality of life utility index comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels where 1 indicates better health state (no problems) and 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; a positive change indicates an improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=173 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in European Quality of Life Utility Index: After Approx 19 and 25 Months Month 19 (Change from baseline)	0.011 Scores on a scale Standard Deviation 0.184	-0.028 Scores on a scale Standard Deviation 0.047	—
Patient Reported Outcomes - Change in European Quality of Life Utility Index: After Approx 19 and 25 Months Month 25 (Change from Month 19)	-0.025 Scores on a scale Standard Deviation 0.174	-0.028 Scores on a scale Standard Deviation 0.093	—

SECONDARY outcome

Timeframe: 1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.

Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It is possible that a patient answers more than one questionnaire in a single time interval. Overall units analysed = Max no. of questionnaires answered by participants for this endpoint. Overall no. of participants analysed = max no. of participants analysed at each time point. This utility index has 5 dimensions: mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. Each dimension has 3 levels where 1 indicates better health state (no problems) and 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; a positive change indicates an improvement.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=164 Number of questionnaires Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=5 Number of questionnaires Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months 1 to <2 years (Change from baseline)	0.052 Scores on a scale Standard Deviation 0.252	—	—
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months 2 to <3 years (Change from baseline)	-0.008 Scores on a scale Standard Deviation 0.159	0.000 Scores on a scale Standard Deviation 0.000	—
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months 3 to <4 years (Change from baseline)	0.021 Scores on a scale Standard Deviation 0.193	0.000 Scores on a scale Standard Deviation 0.000	—
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months 4 to <5 years (Change from baseline)	0.000 Scores on a scale Standard Deviation 0.165	-0.001 Scores on a scale Standard Deviation 0.057	—
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months 5 to <6 years (Change from baseline)	0.011 Scores on a scale Standard Deviation 0.178	0.000 Scores on a scale Standard Deviation 0.000	—
Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months 6 to <7 years (Change from baseline)	-0.062 Scores on a scale Standard Deviation 0.163	0.000 Scores on a scale Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: After approx 19, 25 and 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The number of hospital admissions that took place in the study were reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=110 Number of hospital admissions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Number of hospital admissions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Hospital Admissions During the Trial After approximately 19 months · 0	49 Number of hospital admissions	8 Number of hospital admissions	—
Number of Hospital Admissions During the Trial After approximately 19 months · 1	3 Number of hospital admissions	0 Number of hospital admissions	—
Number of Hospital Admissions During the Trial After approximately 19 months · 2	0 Number of hospital admissions	0 Number of hospital admissions	—
Number of Hospital Admissions During the Trial After approximately 25 months · 0	84 Number of hospital admissions	8 Number of hospital admissions	—
Number of Hospital Admissions During the Trial After approximately 25 months · 1	4 Number of hospital admissions	2 Number of hospital admissions	—
Number of Hospital Admissions During the Trial After approximately 25 months · 2	1 Number of hospital admissions	0 Number of hospital admissions	—
Number of Hospital Admissions During the Trial Month 25 to Month 80 · 0	20 Number of hospital admissions	2 Number of hospital admissions	—
Number of Hospital Admissions During the Trial Month 25 to Month 80 · 1	1 Number of hospital admissions	0 Number of hospital admissions	—
Number of Hospital Admissions During the Trial Month 25 to Month 80 · 2	0 Number of hospital admissions	0 Number of hospital admissions	—

SECONDARY outcome

Timeframe: After approx 19, 25 and 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean number of days that participants spent at the hospital during the study were reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Days at the Hospital During the Trial After approximately 19 months	0.1 Days Standard Deviation 0.4	0.0 Days Standard Deviation 0.0	—
Number of Days at the Hospital During the Trial After approximately 25 months	0.5 Days Standard Deviation 3.8	0.7 Days Standard Deviation 1.6	—
Number of Days at the Hospital During the Trial Month 25 to 80	0.5 Days Standard Deviation 2.4	0.0 Days Standard Deviation 0.0	—

SECONDARY outcome

Timeframe: After approx 19, 25 and 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The number of admissions to the ER that took place in the study were reported for each group.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=110 ER admissions Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 ER admissions Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 19 months · 0	49 ER admissions	8 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 19 months · 1	1 ER admissions	0 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 19 months · 2	2 ER admissions	0 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 19 months · 4	0 ER admissions	0 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 25 months · 0	84 ER admissions	8 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 25 months · 1	2 ER admissions	1 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 25 months · 2	2 ER admissions	1 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial After approximately 25 months · 4	1 ER admissions	0 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial Month 25 to 80 · 0	17 ER admissions	2 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial Month 25 to 80 · 1	4 ER admissions	0 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial Month 25 to 80 · 2	0 ER admissions	0 ER admissions	—
Number of Admissions to the Emergency Room (ER) During the Trial Month 25 to 80 · 4	0 ER admissions	0 ER admissions	—

SECONDARY outcome

Timeframe: Approx 19, 25 and 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean number of days that participants missed to go to school or work were reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Days Missing School or Work After approximately 19 months	0.5 Days Standard Deviation 1.6	6.7 Days Standard Deviation 16.9	—
Number of Days Missing School or Work After approximately 25 months	0.8 Days Standard Deviation 2.0	6.8 Days Standard Deviation 16.9	—
Number of Days Missing School or Work Month 25 to 80	2.6 Days Standard Deviation 14.4	0.3 Days Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: Approx 19, 25 and 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean number of days that participants used any aids for mobility during the study were reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Days Using Mobility Aid After approximately 24 months	4.4 Days Standard Deviation 26.2	11.1 Days Standard Deviation 34.7	—
Number of Days Using Mobility Aid After approximately 36 months	7.0 Days Standard Deviation 42.7	5.8 Days Standard Deviation 15.9	—
Number of Days Using Mobility Aid Month 25 to 80	1.0 Days Standard Deviation 4.6	0.5 Days Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: After approx 25 and 80 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The number of participants using pain medication during the main plus extension phase 1 of the study (approximately 25 months) and during extension phase 2(approximately 80 months) were reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Participants Using Pain Medication After approximately 25 months · Yes	19 Participants	2 Participants	—
Number of Participants Using Pain Medication After approximately 25 months · No	39 Participants	5 Participants	—
Number of Participants Using Pain Medication Month 25 to 80 · Yes	5 Participants	1 Participants	—
Number of Participants Using Pain Medication Month 25 to 80 · No	13 Participants	0 Participants	—

SECONDARY outcome

Timeframe: After approx 19 months

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean number of bleeds using pain medication in the main phase of the study (approximately 19 months) were reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Bleeds Using Pain Medication	0.1 Number of bleeds Standard Deviation 0.4	0.5 Number of bleeds Standard Deviation 1.4	—

SECONDARY outcome

Timeframe: After approx 19 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.

All presented adverse events (AEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=175 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Adverse Events Reported During the Trial Period: After Approximately 19 Months	423 Number of adverse events	51 Number of adverse events	—

SECONDARY outcome

Timeframe: After approx. 25 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.

All presented adverse events (AEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=175 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=38 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Adverse Events Reported During the Trial Period: After Approximately 25 Months	701 Number of adverse events	71 Number of adverse events	75 Number of adverse events

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.

The number of adverse events observed during the study after approximately 80 months was reported.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Adverse Events Reported During the Trial Period: After Approximately 80 Months	1326 Number of adverse events	369 Number of adverse events	132 Number of adverse events

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.

All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=175 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 19 Months	13 Number of serious adverse events	4 Number of serious adverse events	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.

All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=175 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 25 Months	27 Number of serious adverse events	1 Number of serious adverse events	4 Number of serious adverse events

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.

All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=61 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Number of Serious Adverse Events Reported During the Trial Period: After Approximately 80 Months	39 Number of serious adverse events	16 Number of serious adverse events	8 Number of serious adverse events

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the systolic and diastolic blood pressure values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Blood Pressure: After Approximately 19 Months Systolic blood pressure	6.8 mmHg Standard Deviation 9.5	1.3 mmHg Standard Deviation 20.5	—
Change in Blood Pressure: After Approximately 19 Months Diastolic blood pressure	3.3 mmHg Standard Deviation 8.9	9.0 mmHg Standard Deviation 5.2	—

SECONDARY outcome

Timeframe: After approximately 19 and 25 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the systolic and diastolic blood pressure values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Blood Pressure: After Approximately 25 Months Systolic blood pressure	-1.337 mmHg Standard Deviation 13.1	-6.000 mmHg Standard Deviation 9.5	—
Change in Blood Pressure: After Approximately 25 Months Diastolic blood pressure	0.337 mmHg Standard Deviation 10.8	2.000 mmHg Standard Deviation 5.9	—

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Data were not collected for this outcome measure.

Change in the blood pressure was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the pulse values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Pulse: After Approximately 19 Months	5.3 Beats per min Standard Deviation 11.2	10.3 Beats per min Standard Deviation 4.6	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the pulse values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Pulse: After Approximately 25 Months	-0.644 Beats per min Standard Deviation 10.7	3.143 Beats per min Standard Deviation 8.2	—

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Data were not collected for this outcome measure.

Change in pulse was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the body temperature values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Body Temperature: After Approximately 19 Months	0.0 Degree celcius Standard Deviation 0.4	-0.1 Degree celcius Standard Deviation 0.2	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the body temperature (C) values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Body Temperature: After Approximately 25 Months	-0.079 Degree celcius Standard Deviation 0.3	-0.086 Degree celcius Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Data were not collected for this outcome measure.

Change in body temperature was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After approximately 19 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the respiratory rate values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Respiratory Rate: After Approximately 19 Months	-0.2 Breaths/min Standard Deviation 1.9	-2.3 Breaths/min Standard Deviation 2.1	—

SECONDARY outcome

Timeframe: After approximately 25 months

Population: Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

The mean change in the respiratory rate (breaths/min) values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=177 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand n=12 Participants Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Change in Respiratory Rate: After Approximately 25 Months	-0.067 Breaths/min Standard Deviation 2.1	-0.857 Breaths/min Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: After approximately 80 months

Population: Data were not collected for this outcome measure.

Change in respiratory rate was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0, week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

FVIII plasma activity was measured after 30 mins of injection. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
FVIII Activity 30 Min Post -Injection (C30min) Week 0	1.524 IU/mL Geometric Coefficient of Variation 22.65	—	—
FVIII Activity 30 Min Post -Injection (C30min) Week 28	1.601 IU/mL Geometric Coefficient of Variation 16.24	—	—

SECONDARY outcome

Timeframe: Week 0, week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Incremental recovery was defined as the dose-normalised activity recorded 30 min after end of injection. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Incremental Recovery (Single Dose and Steady State) Week 0	0.031 [(U/mL)/(IU/kg)] Geometric Coefficient of Variation 22.16	—	—
Incremental Recovery (Single Dose and Steady State) Week 28	0.034 [(U/mL)/(IU/kg)] Geometric Coefficient of Variation 17.60	—	—

SECONDARY outcome

Timeframe: Week 0, week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Trough level was defined as the plasma FVIII activity recorded immediately before next dose is given. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Trough Level (Single Dose and Steady State) Week 0	0.032 IU/mL Geometric Coefficient of Variation 138.3	—	—
Trough Level (Single Dose and Steady State) Week 28	0.035 IU/mL Geometric Coefficient of Variation 138.4	—	—

SECONDARY outcome

Timeframe: Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf) was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. It is the measure of total plasma exposure. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Area Under the Curve (AUC0-inf) Week 0	39.77 IU*h/mL Geometric Coefficient of Variation 34.41	—	—
Area Under the Curve (AUC0-inf) Week 28	41.44 IU*h/mL Geometric Coefficient of Variation 30.09	—	—

SECONDARY outcome

Timeframe: Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Area under the plasma activity versus time profile from time zero to the last measurable activity (AUC0-t) was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Area Under the Curve (AUC0-t) Week 0	38.31 IU*h/mL Geometric Coefficient of Variation 33.22	—	—
Area Under the Curve (AUC0-t) Week 28	39.87 IU*h/mL Geometric Coefficient of Variation 28.22	—	—

SECONDARY outcome

Timeframe: Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

t½ = ln(2) / λz, where λz is the terminal elimination rate constant. The terminal elimination rate constant was estimated using linear regression on the terminal part of the log(activity) versus time profile. This was measured at Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Terminal Half Life (t1/2) Week 0	18.27 Hour (h) Geometric Coefficient of Variation 27.40	—	—
Terminal Half Life (t1/2) Week 28	18.18 Hour (h) Geometric Coefficient of Variation 31.43	—	—

SECONDARY outcome

Timeframe: Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Total plasma clearance (CL) of drug after intravenous administration was reported. Clearance was calculated using the formula CL= Dose / AUC(0-inf). This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Clearance (CL) Week 0	1.210 mL/h/kg Geometric Coefficient of Variation 33.22	—	—
Clearance (CL) Week 28	1.139 mL/h/kg Geometric Coefficient of Variation 29.24	—	—

SECONDARY outcome

Timeframe: Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

MRT = AUMC/AUC(0-inf), where AUMC is the area under the first moment curve, i.e. the area under the curve t∙C(t), calculated with the same method as AUC(0-inf) (linear trapezoidal method + extrapolated area). This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Mean Residence Time (MRT) Week 0	25.12 Hour (h) Geometric Coefficient of Variation 27.43	—	—
Mean Residence Time (MRT) Week 28	24.91 Hour (h) Geometric Coefficient of Variation 32.25	—	—

SECONDARY outcome

Timeframe: Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28

Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.

Apparent volume of distribution at steady state is a product of the mean residence time and clearance and was calculated using the formula - Vss = CL x MRT. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.

Outcome measures

Outcome measures
Measure	N8-GP 50 U/kg Prophylaxis Q4D n=24 Participants Participants received one single bolus dose of 50 U/kg of body weight (BW) of N8-GP administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). The dose was based on phase 1 data from the NN7088-3776 trial in order to ensure a trough level of \>1% FVIII:C activity in the majority of participants in the prophylaxis arm.	N8-GP 20-75 U/kg On-demand Participants received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.	N8-GP 20-75 U/kg On-demand Participants in this arm received treatment with N8-GP in case of a bleeding episode. All bleeds were to be treated with doses between 20-75 U/kg BW according to the severity and location of the bleeding episode. The dosage (N8-GP units) was calculated by multiplying the participant's weight in kilograms by the desired factor level multiplied by 0.5.
Volume of Distribution at Steady State (Vss) Week 0	30.40 mL/kg Geometric Coefficient of Variation 24.18	—	—
Volume of Distribution at Steady State (Vss) Week 28	28.38 mL/kg Geometric Coefficient of Variation 19.43	—	—

Adverse Events

N8-GP 50 U/kg Q4D Prophylaxis

Serious events: 24 serious events

Other events: 144 other events

Deaths: 1 deaths

N8-GP 75 U/kg Q7D Prophylaxis

Serious events: 7 serious events

Other events: 50 other events

Deaths: 0 deaths

N8-GP 20-75 U/kg On-demand

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER