Trial Outcomes & Findings for Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE) (NCT NCT04180163)

NCT ID: NCT04180163

Last Updated: 2022-09-30

Results Overview

A participant was considered as attack free during an efficacy evaluation period if the participant had no investigator-confirmed hereditary angioedema (HAE) attacks during that efficacy evaluation period. A HAE attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants achieving attack-free status for the efficacy evaluation period of Day 0 through Day 182 were assessed.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: Day 0 through Day 182
• Results posted on: 2022-09-30

Participant Flow

A total of 12 participants took part in the study at 10 investigative sites in Japan from 12 December 2019 to 26 August 2021.

Enrolled participants were observed in 4-week Baseline Run-in Period that could be extended up to 8 weeks. Participants who experienced ≥1.0 angioedema attacks per 4 weeks during the Run-in Period and who remained eligible per inclusion criteria entered 52-week lanadelumab Treatment Period (Treatment Period A + Treatment Period B), followed by up to 4-week Safety Follow-up Period. Participants received lanadelumab only during the Treatment Periods.

Participant milestones

Measure	Lanadelumab 300 mg q2w or q4w Lanadelumab 300 mg solution, subcutaneously (SC), once every 2 weeks (q2w) for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution once every 4 weeks (q4w) for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.
Run-in Period (4 or up to 8 Weeks) STARTED	12
Run-in Period (4 or up to 8 Weeks) COMPLETED	12
Run-in Period (4 or up to 8 Weeks) NOT COMPLETED	0
Treatment Period A (Weeks 1 to 26) STARTED	12
Treatment Period A (Weeks 1 to 26) COMPLETED	12
Treatment Period A (Weeks 1 to 26) NOT COMPLETED	0
Treatment Period B (Weeks 27 to 52) STARTED	12
Treatment Period B (Weeks 27 to 52) COMPLETED	12
Treatment Period B (Weeks 27 to 52) NOT COMPLETED	0
Safety Follow-up Period (Weeks 53 to 56) STARTED	12
Safety Follow-up Period (Weeks 53 to 56) COMPLETED	12
Safety Follow-up Period (Weeks 53 to 56) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)

Baseline characteristics by cohort

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.
Age, Continuous	41.9 years STANDARD_DEVIATION 12.36 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Japan	12 Participants n=5 Participants
Weight	61.24 kg STANDARD_DEVIATION 10.346 • n=5 Participants
Height	161.08 cm STANDARD_DEVIATION 9.379 • n=5 Participants
Body Mass Index (BMI)	23.80 kg/m^2 STANDARD_DEVIATION 5.065 • n=5 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 182

Population: FAS included all participants who received at least 1 dose of IMP.

A participant was considered as attack free during an efficacy evaluation period if the participant had no investigator-confirmed hereditary angioedema (HAE) attacks during that efficacy evaluation period. A HAE attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants achieving attack-free status for the efficacy evaluation period of Day 0 through Day 182 were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period of Day 0 Through Day 182	5 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. Number of investigator-confirmed HAE attacks during each of the efficacy evaluation periods were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 0 Through Day 182	92 HAE attacks	—	—	—	—	—
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 0 Through Day 364	189 HAE attacks	—	—	—	—	—
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 70 Through Day 182	55 HAE attacks	—	—	—	—	—
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 70 Through Day 364	152 HAE attacks	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. Number of investigator-confirmed HAE attacks requiring acute treatment during each of the efficacy evaluation periods were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods Day 70 Through Day 182	46 HAE attacks	—	—	—	—	—
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods Day 0 Through Day 182	79 HAE attacks	—	—	—	—	—
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods Day 0 Through Day 364	168 HAE attacks	—	—	—	—	—
Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods Day 70 Through Day 364	135 HAE attacks	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

Severe attack was defined as Grade 3 (some assistance usually required, medical intervention/therapy required, hospitalizations possible), moderate attack was defined as Grade 2 (some assistance may be needed, no or minimal medical intervention/therapy required). Number of investigator-confirmed moderate or severe HAE attacks during the each of efficacy evaluation periods was assessed. Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 0 Through Day 182	72 HAE attacks	—	—	—	—	—
Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 0 Through Day 364	153 HAE attacks	—	—	—	—	—
Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 70 Through Day 182	41 HAE attacks	—	—	—	—	—
Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 70 Through Day 364	122 HAE attacks	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. Number of participants with maximum HAE attack severity during each of the efficacy evaluation periods was assessed. HAE attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 182: No Attack	5 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 182: Mild	2 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 182: Moderate	4 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 182: Severe	1 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 364: No Attack	2 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 364: Mild	1 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 364: Moderate	8 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 0 Through Day 364: Severe	1 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 182: No Attack	5 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 182: Mild	4 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 182: Moderate	2 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 182: Severe	1 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 364: No Attack	2 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 364: Mild	2 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 364: Moderate	7 Participants	—	—	—	—	—
Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods Day 70 Through Day 364: Severe	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

A high morbidity HAE attack was defined as any attack that has at least 1 of the following characteristics: severe, results in hospitalization (except hospitalization for observation <24 hours), hemodynamically significant (systolic blood pressure <90, requires intravenous (IV) hydration, or associated with syncope or near syncope) or laryngeal. Number of high-morbidity investigator-confirmed HAE attacks during each of the 4 efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A and Overall Presumed Steady-state Period) were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 0 Through Day 182	5 HAE attacks	—	—	—	—	—
Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 0 Through Day 364	11 HAE attacks	—	—	—	—	—
Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 70 Through Day 182	4 HAE attacks	—	—	—	—	—
Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods Day 70 Through Day 364	10 HAE attacks	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182

Population: FAS included all participants who received at least 1 dose of IMP.

The time to the first HAE attack (days) after Day 0 for the efficacy evaluation period of Day 0 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 0 through Day 182) to the date and time of the first in HAE attack after the first open-label dose for the efficacy evaluation period of Day 0 through Day 182. Kaplan-Meier Method was used for analysis and the Kaplan Meier estimate expressed as time (in days) to first HAE attack After Day 0 for Treatment Period A (Day 0 through Day 182) is presented.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period	97.2 days Interval 4.2 to The upper limit of 95% confidence interval (CI) was not evaluable due to low number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 70 through Day 182

Population: FAS included all participants who received at least 1 dose of IMP.

The time to the first HAE attack (days) after Day 0 for the efficacy evaluation period of Day 70 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 70 through Day 182) to the date and time of the first in HAE attack after the first open-label dose for the efficacy evaluation period of Day 70 through Day 182. Kaplan-Meier Method was used for analysis and the Kaplan Meier estimate expressed as time (in days) to first HAE attack After Day 0 for presumed steady-state period for Treatment Period A (Day 70 through Day 182) is presented.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period	91.0 days Interval 4.6 to The upper limit of 95% CI was not evaluable due to low number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

Run- in Period was 4 weeks and may have been extended up to 8 weeks to determine participants' Baseline attack rate. The normalized number of investigator-confirmed HAE attacks (NNA) during each efficacy evaluation period will be expressed as a monthly (28 days) HAE attack rate. Number of participants achieving at least 50%, 70% and 90% reduction in the investigator-confirmed NNA per 4 weeks relative to the Run-in Period normalized NNA for each of the 4 efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A, and Overall Presumed Steady-state Period) were assessed. For each participant, the percentage reduction was calculated as the run-in period attack rate minus the treatment period attack rate divided by the run-in period attack rate, multiplied by 100. The responder categories were not mutually exclusive, participants may appear in more than one category as applicable based on their percentage reduction.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 0 Through Day 182: ≥90% Reduction	6 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 0 Through Day 182: ≥50% Reduction	10 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 0 Through Day 182: ≥70% Reduction	8 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 0 Through Day 364: ≥50% Reduction	10 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 0 Through Day 364: ≥70% Reduction	8 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 0 Through Day 364: ≥90% Reduction	6 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 70 Through Day 182: ≥50% Reduction	11 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 70 Through Day 182: ≥70% Reduction	10 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 70 Through Day 182: ≥90% Reduction	6 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 70 Through Day 364: ≥50% Reduction	10 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 70 Through Day 364: ≥70% Reduction	8 Participants	—	—	—	—	—
Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods Day 70 Through Day 364: ≥90% Reduction	7 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

The NNA (investigator-confirmed) during each efficacy evaluation period was expressed as a monthly (28 days) HAE attack rate. Number of participants achieving NNA <1.0 per 4 weeks, <0.75 per 4 weeks, <0.50 per 4 weeks, and <0.25 per 4 weeks for each of the 4 efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A, and Overall Presumed Steady-state Period) were assessed. The responder categories were not mutually exclusive, participants may appear in more than one category as applicable based on their HAE attack rate.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 364: <0.75 per Month	8 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 364: <0.25 per Month	6 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 182: <1.0 per Month	9 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 182: <0.75 per Month	9 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 182: <0.50 per Month	6 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 182: <0.25 per Month	6 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 364: <1.0 per Month	9 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 364: <0.75 per Month	8 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 364: <0.50 per Month	7 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 0 Through Day 364: <0.25 per Month	6 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 182: <1.0 per Month	9 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 182: <0.75 per Month	9 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 182: <0.50 per Month	8 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 182: <0.25 per Month	6 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 364: <1.0 per Month	9 Participants	—	—	—	—	—
Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods Day 70 Through Day 364: <0.50 per Month	7 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 364, Day 70 through Day 182, and Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP. Overall number analyzed are the number of participants who achieved attack-free status during an efficacy evaluation period.

A participant was considered as attack free during an efficacy evaluation period if the participant had no investigator-confirmed HAE attacks during that efficacy evaluation period. A HAE attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants achieving attack-free status for the 4 efficacy evaluation periods (Overall Treatment Period, Presumed Steady-state Period for Treatment Period A, and Overall Presumed Steady-state Period) were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=9 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period Day 0 Through Day 364, Day 70 Through Day 182, and Day 70 Through Day 364 Day 0 Through Day 364	2 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period Day 0 Through Day 364, Day 70 Through Day 182, and Day 70 Through Day 364 Day 70 Through Day 182	5 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period Day 0 Through Day 364, Day 70 Through Day 182, and Day 70 Through Day 364 Day 70 Through Day 364	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13

Population: FAS included all participants who received at least 1 dose of IMP.

A participant was considered as attack free during an efficacy evaluation period if the participant had no investigator-confirmed HAE attacks during that efficacy evaluation period. A HAE attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 1	7 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 2	8 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 3	9 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 4	7 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 5	9 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 6	7 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 7	8 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 8	6 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 9	7 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 10	9 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 11	8 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 12	7 Participants	—	—	—	—	—
Number of Participants Achieving Attack-Free Status for Monthly Increments Month 13	8 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182

Population: FAS included all participants who received at least 1 dose of IMP.

A participant was considered as attack free during a time period if the participant had no investigator-confirmed HAE attacks during that time period. Participants who discontinued during a time period were considered as non-responders for that time period. Number of participants achieving investigator-confirmed HAE attack free intervals from Day 0 through Day 182 were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants Achieving Investigator-Confirmed Hereditary Angioedema (HAE) Attack-Free Intervals	5 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364

Population: FAS included all participants who received at least 1 dose of IMP.

An attack-free day was defined as a calendar day with no investigator-confirmed HAE attack. HAE attack free days were calculated by counting the number of days in the efficacy evaluation period without an HAE attack and dividing by the number of days the participant contributed to the efficacy evaluation period. Percentage of investigator-confirmed HAE attack free days during each of the efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A, and Overall Presumed Steady-state Period) were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Percentage of Attack Free Days During Each of the Efficacy Evaluation Periods Day 0 Through Day 364	89.04 percentage of attack-free days Standard Deviation 27.015	—	—	—	—	—
Percentage of Attack Free Days During Each of the Efficacy Evaluation Periods Day 0 Through Day 182	88.53 percentage of attack-free days Standard Deviation 27.146	—	—	—	—	—
Percentage of Attack Free Days During Each of the Efficacy Evaluation Periods Day 70 Through Day 182	90.34 percentage of attack-free days Standard Deviation 21.952	—	—	—	—	—
Percentage of Attack Free Days During Each of the Efficacy Evaluation Periods Day 70 Through Day 364	89.85 percentage of attack-free days Standard Deviation 25.015	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study drug up to end of study (EOS) (up to Day 392)

Population: FAS included all participants who received at least 1 dose of IMP.

TEAE=any event emerging at or after initiation of treatment with investigational product (IP) or any existing event that worsens in intensity/frequency on exposure to IP. Serious TEAE=any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) at any dose: results in death, was life-threatening, requires inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, important medical event. AESI=investigator-reported hypersensitivity reactions, events of disordered coagulation as bleeding/hypercoagulable AESI. Adverse events were classified as HAE attack and non-HAE attack reported AEs and are categorized accordingly. As Pre-specified in the protocol, TEAEs, SAEs and AESIs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period and data is reported accordingly.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) Any TEAEs	10 Participants Interval 111.0 to	8 Participants	9 Participants	8 Participants	0 Participants	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) AESI	3 Participants Interval 34.0 to	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) Any Serious TEAEs	1 Participants Interval 23.0 to	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose on Days 0, 56, 98, 140, 182, 266, 350, 364, and at any time on Day 378 or 392

Population: Pharmacokinetic (PK) Set included all participants in the FAS who had at least 1 evaluable post dose PK concentration value. Number analyzed is the number of participants available for analysis at a specific time point.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Plasma Concentrations of Lanadelumab Day 364	22329.820 nanograms per milliliter (ng/mL) Standard Deviation 7527.7165	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 0	25.584 nanograms per milliliter (ng/mL) Standard Deviation 50.2034	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 56	23630.973 nanograms per milliliter (ng/mL) Standard Deviation 8665.1099	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 98	24142.776 nanograms per milliliter (ng/mL) Standard Deviation 9575.7596	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 140	24613.885 nanograms per milliliter (ng/mL) Standard Deviation 9319.6672	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 182	23679.526 nanograms per milliliter (ng/mL) Standard Deviation 6793.3003	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 266	19269.249 nanograms per milliliter (ng/mL) Standard Deviation 8870.0355	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 350	13225.533 nanograms per milliliter (ng/mL) Standard Deviation 2538.8239	—	—	—	—	—
Plasma Concentrations of Lanadelumab Day 378/392	19308.033 nanograms per milliliter (ng/mL) Standard Deviation 7708.1882	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 0, 28, 56, 98, 126, 154, 182, 266, 364, 378 or 392

Population: FAS included all participants who received at least 1 dose of IMP.

The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema (including HAE). The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AE-QoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items had a five-point response scale ranging from 1 (Never) to 5 (Very Often). The questionnaire was scored according to the developers' guidelines to produce 4 domain scores (functioning, fatigue/mood, fear/shame, nutrition) yielding a total score. The raw total score (mean of all item scores) was rescaled using linear transformations into final percentage scores ranging 0 to 100, based on the maximum possible score, where higher the score, greater the QoL impairment.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 0	46.57 score on a scale Standard Deviation 20.885	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 28	26.35 score on a scale Standard Deviation 31.129	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 56	28.43 score on a scale Standard Deviation 28.255	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 98	26.96 score on a scale Standard Deviation 30.926	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 126	32.60 score on a scale Standard Deviation 33.999	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 154	21.69 score on a scale Standard Deviation 28.750	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 182	26.10 score on a scale Standard Deviation 33.978	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 266	26.96 score on a scale Standard Deviation 29.951	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 364	26.59 score on a scale Standard Deviation 34.428	—	—	—	—	—
Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score Day 378/392	28.55 score on a scale Standard Deviation 31.934	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Days 0, 56, 98, 140, 182, 266, 350, 364, and at any time on Day 378 or 392

Population: Pharmacodynamic (PD) Set included all participants in the FAS who had at least 1 evaluable post dose PD value. Number analyzed is the number of participants with data available for analysis at the given time point.

pKal activity was measured by biomarker cleaved high molecular weight kininogen (cHMWK) level to assess pharmacodynamics (PD) of lanadelumab.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Plasma Kallikrein (pKal) Activity Day 0	63.04 percentage of cHMWK Standard Deviation 22.096	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 56	30.88 percentage of cHMWK Standard Deviation 17.090	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 98	32.40 percentage of cHMWK Standard Deviation 18.829	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 140	35.67 percentage of cHMWK Standard Deviation 13.787	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 182	30.31 percentage of cHMWK Standard Deviation 17.344	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 266	21.69 percentage of cHMWK Standard Deviation 11.221	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 350	39.83 percentage of cHMWK Standard Deviation 12.407	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 364	27.51 percentage of cHMWK Standard Deviation 12.901	—	—	—	—	—
Plasma Kallikrein (pKal) Activity Day 378/392	40.65 percentage of cHMWK Standard Deviation 15.828	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose on Days 0 (or Baseline), 56, 98, 140, 182, 266, 350, 364, and at any time on Day 378 or 392

Population: FAS included all participants who received at least 1 dose of IMP. Number analyzed is the number of participants with data available for analysis at the given time point.

Baseline was defined as the last non-missing value prior to first dose of study drug (based on date or date/time).

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 182	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 0 (or Baseline)	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 56	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 98	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 140	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 266	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 350	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 364	0 Participants	—	—	—	—	—
Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma Day 378/392	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study drug up to end of study (EOS) (up to Day 392)

Population: FAS included all participants who received at least 1 dose of IMP.

A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. As Pre-specified in the protocol, the treatment emergent adverse events were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period. Number of participants with TEAEs related to clinical laboratory tests (hematology, clinical chemistry, coagulation, and urinalysis) were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants With TEAEs Related to Clinical Laboratory Tests	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of the study drug up to end of study (EOS) (up to Day 392)

Population: FAS included all participants who received at least 1 dose of IMP.

A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. As Pre-specified in the protocol, the treatment emergent adverse events were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period. Number of participants with TEAEs related to vital signs (blood pressure (BP), heart rate (HR), body temperature, and respiratory rate) were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants With TEAEs Related to Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of the study drug up to end of study (EOS) (up to Day 392)

Population: FAS included all participants who received at least 1 dose of IMP.

A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. As Pre-specified in the protocol, the treatment emergent adverse events were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period. Number of participants with TEAEs related to 12 lead-ECG were assessed.

Outcome measures

Measure	Lanadelumab 300 mg q2w or q4w n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. This was followed by Treatment Period B (additional 26 weeks, total of 52 weeks including Treatment Period A) during which participants remained on Treatment Period A regimen or received 300 mg lanadelumab solution q4w for 26 weeks if well-controlled (attack-free) for 26 consecutive weeks with lanadelumab treatment. The dose frequency change was based on the Investigator's discretion and approval by the Sponsor's Medical Monitor.	Treatment Period A: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE n=12 Participants Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007 \[NCT04687137\]) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE n=12 Participants Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Number of Participants With TEAEs Related to Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Treatment Period A: Non-HAE

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Treatment Period A: HAE

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Treatment Period B: Non-HAE

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Treatment Period B: HAE

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Safety Follow-up Period: Non-HAE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Safety Follow-up Period: HAE

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Period A: Non-HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period A: HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE n=12 participants at risk Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE n=12 participants at risk Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Psychiatric disorders Anxiety disorder	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Device related infection	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Congenital, familial and genetic disorders Hereditary angioedema	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.

Other adverse events

Measure	Treatment Period A: Non-HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period A: HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks in Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Treatment Period B: Non-HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Treatment Period B: HAE n=12 participants at risk Lanadelumab 300 mg solution, SC, q2w for 26 weeks or lanadelumab 300 mg solution, SC, q4w for 26 weeks in Treatment Period B if well tolerated (attack-free) for 26 consecutive weeks with lanadelumab treatment during Treatment Period A. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: Non-HAE n=12 participants at risk Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. Non-HAE attack (subset identified in CRF as not reported HAE attack) subset participants were included in this arm.	Safety Follow-up Period: HAE n=12 participants at risk Participants who completed the lanadelumab 300 mg regimen in Treatment Period B returned on Day 378 (for participants who chose to roll over into study TAK-743-5007) or Day 392 as follow-up visit for final assessment in the Safety Follow-up Period. HAE attack (subset of AEs identified in CRF as reported HAE attack) subset participants were included in this arm.
Cardiac disorders Palpitations	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Ear and labyrinth disorders Vertigo	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Vomiting	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Abdominal pain upper	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Constipation	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Dental caries	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Gingival bleeding	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Large intestine polyp	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Nausea	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Gastrointestinal disorders Toothache	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Injection site reaction	50.0% 6/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Injection site erythema	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Injection site pruritus	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Pyrexia	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Chest pain	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Infusion site pruritus	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Injection site pain	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Injection site swelling	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Malaise	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
General disorders Non-cardiac chest pain	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Immune system disorders Allergy to chemicals	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Immune system disorders Anaphylactic shock	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Immune system disorders Contrast media allergy	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Immune system disorders Drug hypersensitivity	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Cystitis	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Nasopharyngitis	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Furuncle	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Gingivitis	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Laryngopharyngitis	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Oral herpes	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Infections and infestations Vulvitis	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	11.1% 1/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Fall	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Heat illness	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Skin abrasion	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Thermal burn	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Injury, poisoning and procedural complications Tooth fracture	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Metabolism and nutrition disorders Decreased appetite	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Metabolism and nutrition disorders Dehydration	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Metabolism and nutrition disorders Diabetes mellitus	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	11.1% 1/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Nervous system disorders Headache	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Nervous system disorders Hypoaesthesia	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Nervous system disorders Intercostal neuralgia	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Psychiatric disorders Anxiety disorder	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	11.1% 1/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/9 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 2/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Alopecia areata	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Angioedema	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Dermatitis contact	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Eczema	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	8.3% 1/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.
Congenital, familial and genetic disorders Hereditary angioedema	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	58.3% 7/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	66.7% 8/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	0.00% 0/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.	25.0% 3/12 • From first dose of the study drug up to end of study (EOS) (up to Day 392) FAS included all participants who received at least 1 dose of IMP. As Pre-specified in the protocol, the TEAEs were collected per Period i.e., Treatment Period A, B and Safety follow-up Period. The data is reported as per HAE attack and non-HAE attack per Period.

Additional Information

Study Director

Takeda

Phone: +1 866 842 5335

Email: ClinicalTransparency@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER