Trial Outcomes & Findings for Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B (NCT NCT01425723)

Last Updated: 2020-12-19

Results Overview

An inhibitor test result greater than or equal to (\>=)0.6 Bethesda units per milliliter (BU/mL), confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Data was summarized by treatment regimen for participants from Study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from Study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

Approximately 5 years

Results posted on

2020-12-19

Participant Flow

Participants who completed either of the Phase 3 studies (Study 998HB102 \[NCT01027364\], Study 9HB02PED \[NCT01440946\]) were expected to be eligible to enroll in this study.

Participant milestones

Participant milestones
Measure	rFIXFc (Participants From 9HB02PED) Participants received Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) intravenously (IV) according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of greater than (\>)5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 international units per kilogram (IU/kg) to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5 percent (%), if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Overall Study STARTED	27	93
Overall Study Weekly Prophylaxis	23	51
Overall Study Individualized Prophylaxis	5	31
Overall Study Personalized Prophylaxis	2	17
Overall Study Episodic	0	15
Overall Study Surgery Subgroup	1	15
Overall Study COMPLETED	23	75
Overall Study NOT COMPLETED	4	18

Reasons for withdrawal

Reasons for withdrawal
Measure	rFIXFc (Participants From 9HB02PED) Participants received Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) intravenously (IV) according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of greater than (\>)5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 international units per kilogram (IU/kg) to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5 percent (%), if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	0	3
Overall Study Physician Decision	2	0
Overall Study Other	1	10

Baseline Characteristics

Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rFIXFc (Participants From 9HB02PED) n=27 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \>5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.	Total n=120 Participants Total of all reporting groups
Age, Customized <18 years	27 Participants n=5 Participants	8 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized Between 18 and 65 years	0 Participants n=5 Participants	85 Participants n=7 Participants	85 Participants n=5 Participants
Age, Customized > 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	93 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	78 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants	47 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	27 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 5 years

Population: Safety Analysis Set included participants who received at least 1 dose of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in study 9HB01EXT.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=13 Participants Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=14 Participants Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Number of Participants With Any Positive Inhibitor Development	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 5 years

Population: Full Analysis Set (FAS) included all participants who received at least 1 dose of rFIXFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.

ABR is annualized number of bleeding episodes per participant per year. Bleeding episodes were classified as spontaneous if participant records bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity and classified as traumatic if participant records bleeding event when there is known reason for bleed. ABR=(Number of bleeding episodes during efficacy period/number of days during efficacy period)\*365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFIXFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. ABR was summarized by treatment regimen for participants from study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=13 Participants Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=14 Participants Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Annualized Bleeding Rate (ABR) Weekly Prophylaxis	1.04 episodes per participant per year Interval 0.0 to 2.28	1.14 episodes per participant per year Interval 0.54 to 2.34	2.26 episodes per participant per year Interval 0.4 to 5.16
Annualized Bleeding Rate (ABR) Episodic	—	—	11.64 episodes per participant per year Interval 5.12 to 18.54
Annualized Bleeding Rate (ABR) Individualized Prophylaxis	—	3.69 episodes per participant per year Interval 3.54 to 5.21	1.85 episodes per participant per year Interval 0.76 to 4.0
Annualized Bleeding Rate (ABR) Personalized Prophylaxis	0.54 episodes per participant per year Interval 0.54 to 0.54	3.13 episodes per participant per year Interval 3.13 to 3.13	2.91 episodes per participant per year Interval 1.14 to 5.36

SECONDARY outcome

Timeframe: Approximately 5 years

Population: FAS included all participants who received at least 1 dose of rFIXFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.

Bleeding episodes were classified as spontaneous if participant records a bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity. In addition, location of bleed (joint, internal, skin/mucosa or muscle) were also collected. Annualized spontaneous joint bleeding episodes=(Number of spontaneous joint bleeding episodes during efficacy period/number of days during efficacy period)\*365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFIXFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Bleeding episodes were summarized by treatment regimen for participants from study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from study 9HB02PED as per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=13 Participants Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=14 Participants Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Annualized Spontaneous Joint Bleeding Episodes Weekly Prophylaxis	0.00 episodes per participant per year Interval 0.0 to 1.06	0.00 episodes per participant per year Interval 0.0 to 1.4	0.38 episodes per participant per year Interval 0.0 to 2.25
Annualized Spontaneous Joint Bleeding Episodes Individualized Prophylaxis	—	0.00 episodes per participant per year Interval 0.0 to 0.29	0.38 episodes per participant per year Interval 0.0 to 1.43
Annualized Spontaneous Joint Bleeding Episodes Personalized Prophylaxis	0.00 episodes per participant per year Interval 0.0 to 0.0	0.00 episodes per participant per year Interval 0.0 to 0.0	0.30 episodes per participant per year Interval 0.0 to 1.37
Annualized Spontaneous Joint Bleeding Episodes Episodic	—	—	2.15 episodes per participant per year Interval 0.58 to 11.68

SECONDARY outcome

Timeframe: Approximately 5 years

Population: Safety Analysis Set included participants who received at least 1 dose of rFIXFc in study 9HB01EXT. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.

An exposure day is a 24-hour period in which one or more rFIXFc injections are given. The total number of days of exposure to rFIXFc were summarized by treatment regimen for participants from study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from study 9HB02PED as per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=13 Participants Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=14 Participants Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Total Number of Exposure Days (EDs) Weekly Prophylaxis	55.00 days Interval 8.0 to 176.0	165.00 days Interval 3.0 to 202.0	169.00 days Interval 4.0 to 327.0
Total Number of Exposure Days (EDs) Individualized Prophylaxis	—	54.00 days Interval 4.0 to 141.0	110.00 days Interval 9.0 to 369.0
Total Number of Exposure Days (EDs) Personalized Prophylaxis	157.00 days Interval 157.0 to 157.0	90.00 days Interval 90.0 to 90.0	146.00 days Interval 7.0 to 431.0
Total Number of Exposure Days (EDs) Episodic	—	—	52.00 days Interval 0.0 to 164.0

SECONDARY outcome

Timeframe: Approximately 5 years

Annualized consumption = (total international unit per kilogram \[IU/kg\] of study treatment received during the efficacy period / total number of days during the efficacy period) multiplied by 365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFIXFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Annualized consumption was summarized by treatment regimen for participants from study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from study 9HB02PED as per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=13 Participants Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=14 Participants Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 Participants Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Annualized rFIXFc Consumption (International Units Per Kilogram [IU/kg]) Personalized Prophylaxis	3331.7 IU per kilogram per participant per year Interval 3331.7 to 3331.7	8931.2 IU per kilogram per participant per year Interval 8931.2 to 8931.2	3671.2 IU per kilogram per participant per year Interval 2394.8 to 5563.3
Annualized rFIXFc Consumption (International Units Per Kilogram [IU/kg]) Weekly Prophylaxis	3382.5 IU per kilogram per participant per year Interval 2930.9 to 3667.4	3212.0 IU per kilogram per participant per year Interval 2838.5 to 3344.4	2598.0 IU per kilogram per participant per year Interval 2129.8 to 3370.9
Annualized rFIXFc Consumption (International Units Per Kilogram [IU/kg]) Individualized Prophylaxis	—	3700.7 IU per kilogram per participant per year Interval 3689.2 to 3716.5	2894.8 IU per kilogram per participant per year Interval 2520.0 to 4023.5
Annualized rFIXFc Consumption (International Units Per Kilogram [IU/kg]) Episodic	—	—	595.6 IU per kilogram per participant per year Interval 363.8 to 1024.5

SECONDARY outcome

Timeframe: Approximately 5 years

Population: FAS included all participants who received at least 1 dose of rFIXFc. Data was summarized by treatment regimen for participants from Study 998HB102 and Study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Participants were assessed for response to their rFIXFc regimen using following 4-point scale: 1=Excellent: bleeding episodes responded to less than or equal to (\<=)usual number of injections or dose of rFIXFc or rate of breakthrough bleeding during prophylaxis was \<= that usually observed; 2=Effective: most bleeding episodes responded to same number of injections and dose, but some required more injections or higher doses, or there was minor increase in rate of breakthrough; 3=Partially Effective: bleeding episodes most often required more injections and/or higher doses than expected or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses and 4=Ineffective: routine failure to control hemostasis/hemostatic control require additional agents. Total number of scale responses =total count of scale responses for all participants; multiple responses per participant including those at scheduled and unscheduled visits are counted.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=151 Responses Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=815 Responses Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Physicians' Global Assessment of Participant's Response to rFIXFc Regimen Using a 4-Point Scale Excellent	131 Responses	622 Responses	—
Physicians' Global Assessment of Participant's Response to rFIXFc Regimen Using a 4-Point Scale Effective	19 Responses	184 Responses	—
Physicians' Global Assessment of Participant's Response to rFIXFc Regimen Using a 4-Point Scale Partially Effective	1 Responses	9 Responses	—
Physicians' Global Assessment of Participant's Response to rFIXFc Regimen Using a 4-Point Scale Ineffective	0 Responses	0 Responses	—

SECONDARY outcome

Timeframe: Approximately 5 years

Population: FAS was analyzed. Data was summarized by treatment regimen for participants from study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Using eDiary, participant received rating for treatment response to any bleeding episode (BE) using 4-point scale- 1=Excellent: Abrupt pain relief and/or improvement in signs of bleeding within approximately (approx.) 8 hours (h) after initial injection (inj.); 2=Good: Definite pain relief and/or improvement in signs of bleeding within approx. 8h after an injection, but possibly requiring more than 1 injection after 24-48h for complete resolution; 3=Moderate: Probable/slight beneficial effect within 8h after initial injection and requires more than 1 injection and 4=None: No improvement, or condition worsens within approx. 8h after initial injection. This assessment was to be made approx. 8 to 12h from time the injection was given to treat BE and prior to any additional doses of rFIXFc given for same bleeding episode. Percentages are based on the number of bleeding episodes for which a response (excellent or good) was provided for the first injection during the efficacy period.

Outcome measures

Outcome measures
Measure	rFIXFc (9HB02PED [<6 Years Old]) n=75 Injections Participants with less than (\<) 6 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (9HB02PED [6 to <12 Years]) n=90 Injections Participants with 6 to \<12 years old age received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \> 5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=1646 Injections Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.
Participant's Assessment of Response (Excellent or Good Response) to rFIXFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale Weekly Prophylaxis	60 Injections	47 Injections	342 Injections
Participant's Assessment of Response (Excellent or Good Response) to rFIXFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale Individualized Prophylaxis	—	25 Injections	336 Injections
Participant's Assessment of Response (Excellent or Good Response) to rFIXFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale Personalized Prophylaxis	0 Injections	1 Injections	135 Injections
Participant's Assessment of Response (Excellent or Good Response) to rFIXFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale Episodic	—	—	603 Injections

Adverse Events

rFIXFc (Participants From 9HB02PED)

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

rFIXFc (Participants From 998HB102)

Serious events: 31 serious events

Other events: 66 other events

Deaths: 0 deaths

Overall rFIXFc (Participants From 9HB02PED and 998HB102)

Serious events: 36 serious events

Other events: 89 other events

Deaths: 0 deaths

rFIXFc (Participants From 9HB02PED in Surgery Subgroup)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

rFIXFc (Participants From 998HB102 in Surgery Subgroup)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rFIXFc (Participants From 9HB02PED) n=27 participants at risk Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \>5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 participants at risk Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.	Overall rFIXFc (Participants From 9HB02PED and 998HB102) n=120 participants at risk All participants who received rFIXFc drug in study 9HB01EXT, from studies 9HB02PED and 998HB102 (combined). AEs emergent during major surgical/rehabilitation periods are excluded and are presented as separate groups.	rFIXFc (Participants From 9HB02PED in Surgery Subgroup) n=1 participants at risk Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFIXFc as appropriate for the type of surgery. Participants returned to a regular rFIXFc regimen once all dosing for the postoperative rehabilitation period had been completed.	rFIXFc (Participants From 998HB102 in Surgery Subgroup) n=15 participants at risk Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFIXFc as appropriate for the type of surgery. Participants returned to a regular rFIXFc regimen once all dosing for the postoperative rehabilitation period had been completed.
Blood and lymphatic system disorders Anaemia	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Eye disorders Necrotising retinitis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Enterocolitis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
General disorders Pain	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Anal abscess	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Cellulitis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.2% 3/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.5% 3/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Hepatitis C	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Orchitis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Pilonidal cyst	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Pneumonia	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Tonsillitis	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Tooth abscess	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Wound infection	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Concussion	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Fall	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.3% 4/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.8% 7/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Foreign body	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Head injury	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Laceration	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.2% 2/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Upper limb fracture	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.2% 2/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Haemophilic arthropathy	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.3% 4/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.3% 4/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Slipping rib syndrome	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Nervous system disorders Epilepsy	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Nervous system disorders Haemorrhage intracranial	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Nervous system disorders Posterior interosseous syndrome	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Renal and urinary disorders Calculus ureteric	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.2% 2/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Renal and urinary disorders Haematuria	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.2% 2/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Renal and urinary disorders Renal colic	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Renal and urinary disorders Renal failure acute	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Respiratory, thoracic and mediastinal disorders Tonsillar haemorrhage	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Social circumstances Victim of crime	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Surgical and medical procedures Knee arthroplasty	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Surgical and medical procedures Tonsillectomy	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Vascular disorders Haematoma	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.83% 1/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Anal Sphincter Atony	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Reproductive system and breast disorders Epididymitis	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.

Other adverse events

Other adverse events
Measure	rFIXFc (Participants From 9HB02PED) n=27 participants at risk Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis (P): Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile in parent study and individual pharmacokinetic profile, trough and/or peak (recovery) values; Individualized P: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized P: included addition of prevention doses prior to strenuous activity; targeting FIX trough level of \>5%, if warranted by bleeding history and/or activity level or dosing twice a week (25 IU/kg twice weekly versus 50 IU/kg once weekly) for participants who may have better control with such regimen. Participants who reached age of 12 during study could also choose to switch to episodic treatment group, with dosing based on participants clinical condition and type and severity of bleeding event.	rFIXFc (Participants From 998HB102) n=93 participants at risk Participants received rFIXFc IV according to their assigned treatment regimen as follows: Weekly prophylaxis: Participants received 20 IU/kg to 100 IU/kg rFIXFc once weekly. Dose was based on participants clinical profile observed in parent study and individual pharmacokinetic profile, trough, and/or peak (recovery) values. Individualized prophylaxis: 100 IU/kg rFIXFc every 8 to 16 days or twice a month; Personalized Prophylaxis: included addition of prevention doses prior to strenuous activity; targeting a FIX trough level of \> 5%, if warranted by the bleeding history and/or activity level or dosing twice a week (25 IU/kg, twice weekly, versus 50 IU/kg, once weekly) for participants who may have better control with such a regimen. Episodic (On Demand): The individual dose of rFIXFc to treat bleeding episodes was based on participants clinical condition, type and severity of the bleeding event.	Overall rFIXFc (Participants From 9HB02PED and 998HB102) n=120 participants at risk All participants who received rFIXFc drug in study 9HB01EXT, from studies 9HB02PED and 998HB102 (combined). AEs emergent during major surgical/rehabilitation periods are excluded and are presented as separate groups.	rFIXFc (Participants From 9HB02PED in Surgery Subgroup) n=1 participants at risk Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFIXFc as appropriate for the type of surgery. Participants returned to a regular rFIXFc regimen once all dosing for the postoperative rehabilitation period had been completed.	rFIXFc (Participants From 998HB102 in Surgery Subgroup) n=15 participants at risk Participants who required emergent or elective surgery while participating in this study and treated with the dose and regimen of rFIXFc as appropriate for the type of surgery. Participants returned to a regular rFIXFc regimen once all dosing for the postoperative rehabilitation period had been completed.
Vascular disorders Hypertension	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	7.5% 7/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.8% 7/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Excoriation	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.5% 3/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Fall	25.9% 7/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.3% 4/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	9.2% 11/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Head injury	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.2% 2/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.3% 4/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Joint dislocation	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Joint injury	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.2% 2/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.3% 4/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Ligament sprain	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.3% 4/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.0% 6/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Laceration	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 8/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Investigations Serum ferritin decreased	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 8/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Respiratory, thoracic and mediastinal disorders Nasal congestion	18.5% 5/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Respiratory, thoracic and mediastinal disorders Epistaxis	18.5% 5/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Immune system disorders Seasonal allergy	14.8% 4/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.2% 3/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.8% 7/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Nervous system disorders Headache	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	16.1% 15/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	15.0% 18/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
General disorders Pyrexia	22.2% 6/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	9.2% 11/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Diarrhoea	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.3% 4/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.0% 6/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Gingival bleeding	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	7.5% 7/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 8/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Nausea	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Toothache	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Vomiting	18.5% 5/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	7.5% 7/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	10.0% 12/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Renal and urinary disorders Haematuria	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Skin and subcutaneous tissue disorders Acne	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Arthralgia	14.8% 4/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	10.8% 10/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	11.7% 14/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Musculoskeletal and connective tissue disorders Pain in extremity	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.5% 3/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Ear infection	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.3% 4/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Influenza	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	8.6% 8/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	7.5% 9/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Hepatitis C	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Lower respiratory tract infection	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.3% 4/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Nasopharyngitis	11.1% 3/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	15.1% 14/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	14.2% 17/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Paronychia	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Tonsillitis	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.7% 2/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Sinusitis	3.7% 1/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.4% 5/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	5.0% 6/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Upper respiratory tract infection	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.5% 6/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 8/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Varicella	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	1.1% 1/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	2.5% 3/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Infections and infestations Viral infection	7.4% 2/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	3.2% 3/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	4.2% 5/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Gastrointestinal disorders Food poisoning	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	13.3% 2/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Psychiatric disorders Insomnia	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Psychiatric disorders Stress	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.
Nervous system disorders Convulsion	0.00% 0/27 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/93 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/120 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	0.00% 0/1 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.	6.7% 1/15 • From signing of Informed Consent Form (ICF) through follow-up (approximately 5 years) Adverse events (AEs) data was planned to be reported for each group and for the overall participants. AEs emergent during major surgical/rehabilitation periods are analyzed separately as per planned analysis and are presented as separate groups.

Additional Information

Bioverativ Study Medical Director

Bioverativ Therapeutics Inc.

Phone: 781-6631801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER