The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. Participants are categorized based on P-VAS score values at both Baseline (0, 1.3, 2, 4 and 5) and Week 4 (0, 0.2, 0.4, 5 and 8). A positive value indicates worsening in pain compared to the baseline score.

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety and negative value indicated worst health.

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health.

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health.

The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

EQ-5D-3L health questionnaire is adult participant and caregivers and EQ-5D-Y is a youth participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =extreme problems) in the relevant health dimension. Higher score indicated a worsening health condition.

The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety.

The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The STAI-S is a psychological assessment tool used to measure the level of anxiety a person is experiencing at a particular moment in time that assesses both State anxiety (STAI-Y1) and Trait anxiety (STAI-Y2). Each type of anxiety has its own scale of 20 different questions each that are scored on a 4-point scale evaluating how respondents feel "right now, at this moment" (e.g. from 'Almost Never to 'Almost Always'). Total scores for each (Y1 and Y2) range from 20 to 80, with higher scores correlating with greater anxiety. Severity for each STAI-Y1 and STAI-Y2 is defined by the scores on STAI-S: 20-35 (very low) 36-45 (low) 46-55 (moderate) 56-65 (high) 66-80 (very high). Number of participants with decrease of at least one level of State-Trait Anxiety Inventory- Severity (STAI-S) are reported.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

Adherence to the VR-based solution was assessed at Week 4 using the MMAS. The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The PGIC is a 7-point Likert scale, a verbal rating scale that asked the respondent to best describe change in symptoms compared to the beginning of study. Participants/caregivers selected from scale range of 1 (very much worsened) to 7 (very much improved). Higher score indicated improved outcome.

Preference for the VR-based solution in participants and caregivers was assessed using a binary question: Yes (Preference for the VR-based solution) and No (preference for VR-based solution) was assessed.

An incident is a minor hardware and/or software event that prevents the correct use of the solution in its context. The incidents were mainly associated with misuse by the user of the solution or with a software and/or hardware failure.

An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. AEs related to infusions of Factor VIII or Factor IX or use of VR-based solution was assessed. An SAE is any untoward medical occurrence that at any dose: results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or any other medically important event that, in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.

Total of all reporting groups

Race and Ethnicity were not collected from any participant.

Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety. Participants are categorized based on their A-VAS score values at both Baseline (-5, -3, 0, and 9.1) and Week 4 (-5, -2.3, -1, 0 and 2). The A-VAS score reported within each category represent the mean difference between the score collected after and before infusion (after minus before). A negative value indicates an improvement in anxiety compared to the baseline score, while a positive value indicates a worsening of anxiety compared to the baseline score.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure were planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy). Here, "number analyzed" signifies participants who were evaluable at specified timepoints for the categories.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain. Participants are categorized based on P-VAS score values at both Baseline (0, 1.3, 2, 4 and 5) and Week 4 (0, 0.2, 0.4, 5 and 8). A positive value indicates worsening in pain compared to the baseline score.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure were planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy). Here, "number analyzed" signifies participants who were evaluable at specified timepoints for the categories.

The pain of participants after each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The P-VAS is a 10 cm line with anchor statements on the left (0: no pain) and on the right (10: extreme pain). An increase in score from 0 to 10 indicated a worsening of pain.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The anxiety of participants and caregivers before each Factor VIII or Factor IX infusion was measured with a 10-points VAS. The A-VAS is a 10 cm line with anchor statements on the left (0:no anxiety) and on the right (10: extreme anxiety). An increase in score from 0 to 10 indicated a worsening of anxiety and negative value indicated worst health.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. As per SAP, the data for this outcome measure was planned to be analyzed for pooled treatment groups (With Autonomy and Without Autonomy).

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to adult participants to assess the effect of the treatment on the participants' quality of life. Adult participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here" overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and" number analyzed" signifies participants who were evaluable at specified timepoints.

The EQ-5D-Y is a standardized instrument for use as a measure of health outcome and was administered to youth participants to assess the effect of the treatment on the participants' quality of life. Youth participants selected answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-Y index score indicated improvement and negative value indicated worst health. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here" overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and" number analyzed" signifies participants who were evaluable at specified timepoints.

EQ-5D-3L health questionnaire is adult participant and caregivers and EQ-5D-Y is a youth participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =extreme problems) in the relevant health dimension. Higher score indicated a worsening health condition.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety (STAI-Y1) and trait anxiety (STAI-Y2). Higher scores were positively correlated with higher levels of anxiety. Each type of anxiety has its own scale of 20 different questions and were rated on a 4-point scale (e.g. from 'Almost Never to 'Almost Always'). Low scores indicated a mild form of anxiety, and high scores indicated a severe form of anxiety. STAI score ranged from 20 to 80 where higher scores indicated greater anxiety and negative value indicated worst anxiety. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The STAI-S is a psychological assessment tool used to measure the level of anxiety a person is experiencing at a particular moment in time that assesses both State anxiety (STAI-Y1) and Trait anxiety (STAI-Y2). Each type of anxiety has its own scale of 20 different questions each that are scored on a 4-point scale evaluating how respondents feel "right now, at this moment" (e.g. from 'Almost Never to 'Almost Always'). Total scores for each (Y1 and Y2) range from 20 to 80, with higher scores correlating with greater anxiety. Severity for each STAI-Y1 and STAI-Y2 is defined by the scores on STAI-S: 20-35 (very low) 36-45 (low) 46-55 (moderate) 56-65 (high) 66-80 (very high). Number of participants with decrease of at least one level of State-Trait Anxiety Inventory- Severity (STAI-S) are reported.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status. Relative variation from baseline at visit (%) = 100 * Absolute change from baseline at visit (in units) / value at baseline (in units).

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options were on a 4-point scale (0 = not at all, 3 = nearly every day). The overall PHQ-9 score ranged from 0 to 27 where 0-5 (none) 5-10 (mild) 10-15 (moderate) 15-20 (moderately severe) 20-27 (severe). Higher values represented more severe depression status.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.

The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behavior. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available.

Adherence to the VR-based solution was assessed at Week 4 using the MMAS. The Morisky Medication Adherence Scale in the original version (MMAS-4) is a structured self-report measure of medication-taking behaviour. It consisted of 4 items, with binary scoring (yes/no). Participants scored one point for every 'Yes' answer. A score of 0 to 1 indicated low adherence; a score of 2 to 3 indicated medium adherence, and a score of 4 indicated high adherence.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

The PGIC is a 7-point Likert scale, a verbal rating scale that asked the respondent to best describe change in symptoms compared to the beginning of study. Participants/caregivers selected from scale range of 1 (very much worsened) to 7 (very much improved). Higher score indicated improved outcome.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

A 4-point Likert scale was used to assess the number of participants, caregivers, and investigators with a score of 3 or 4 (satisfied or very satisfied) with the use of the VR- based system. The Likert scale is composed from 1=never satisfied to 4=very satisfied.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

Preference for the VR-based solution in participants and caregivers was assessed using a binary question: Yes (Preference for the VR-based solution) and No (preference for VR-based solution) was assessed.

The FAS included all the participants of the IS for whose at least one assessment at the Week 4 visit was available. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

An incident is a minor hardware and/or software event that prevents the correct use of the solution in its context. The incidents were mainly associated with misuse by the user of the solution or with a software and/or hardware failure.

The IS included all eligible participants with or without assessment at the end of the Week 4 visit.

An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. AEs related to infusions of Factor VIII or Factor IX or use of VR-based solution was assessed. An SAE is any untoward medical occurrence that at any dose: results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or any other medically important event that, in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

The IS included all eligible participants with or without assessment at the end of the Week 4 visit.

Haemophilia participants without autonomy received Factor VIII or Factor IX infusion using a VR-based solution for 4 weeks. The VR-based solution was provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It included both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.