A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza)

• ClinicalTrials.gov Identifier: NCT03347422
• Recruitment Status: Completed
• First Posted: November 20, 2017
• Results First Posted: December 23, 2022
• Last Update Posted: December 23, 2022
• Sponsor: Bioverativ, a Sanofi company
• Information provided by (Responsible Party): Sanofi ( Bioverativ, a Sanofi company )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Cold Agglutinin Disease
• Interventions: Drug: sutimlimab (BIVV009); Drug: placebo
• Enrollment: 42

Participant Flow

Recruitment Details	The study was conducted at 27 sites in 13 countries. Out of 66 screened participants, a total of 42 participants were enrolled and randomized from 17 March 2018 to 30 March 2020. This study consisted of 2 Parts: Part A and Part B.
Pre-assignment Details	Participants were stratified based on baseline body weight to receive BIVV009 6.5 grams (g) (if <75 kg) or 7.5 g (if >=75 kg). As planned, data presented as: 1) Dose-wise (2 dose cohorts: BIVV009 6.5 g & BIVV009 7.5 g) for safety outcome measures and adverse events (AEs). 2) combined population (BIVV009 at any dose) for efficacy outcome measures.

Arm/Group Title	BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description	Participants with primary Cold Agglutinin Disease (CAD) and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an intravenous (IV) infusion of BIVV009 6.5 g (for participants less than [<]75 kilograms [kg]) or 7.5 g dose (for participants greater than or equal to [>=]75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Period Title: Part A (26 Weeks)
Started	22	20
Completed	19	20
Not Completed	3	0
Reason Not Completed
Adverse Event	3	0
Period Title: Part B (149 Weeks)
Started	19	20
Completed	16	16
Not Completed	3	4
Reason Not Completed
Lack of Efficacy	1	2
Adverse Event	0	1
Withdrawal by Subject	1	1
Other	1	0

Baseline Characteristics

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009	Total
Arm/Group Description		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Total of all reporting groups
Overall Number of Baseline Participants		22	20	42
Baseline Analysis Population Description		Analysis was performed on full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo).
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	22 participants	20 participants	42 participants
		65.3 (10.9)	68.2 (10.1)	66.7 (10.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	20 participants	42 participants
	Female	17 77.3%	16 80.0%	33 78.6%
	Male	5 22.7%	4 20.0%	9 21.4%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	20 participants	42 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	5 22.7%	2 10.0%	7 16.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	4 20.0%	4 9.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	17 77.3%	14 70.0%	31 73.8%

Outcome Measures

1. Primary Outcome

Title	Part A: Percentage of Participants With Response to Treatment
Description	A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to >=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25, and 26 visits). Percentage of responders was calculated together with 95% exact Clopper-Pearson confidence interval (CI).
Time Frame	From Week 5 through Week 26

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part A-full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo). Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A.

Arm/Group Title	BIVV009	Placebo
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed	22	20
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	72.7; (49.8 to 89.3)	15.0; (3.2 to 37.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BIVV009, Placebo
	Comments	A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Threshold for significance was 0.05.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	15.94
	Confidence Interval	(2-Sided) 95%; 2.88 to 88.04
	Estimation Comments	Stratified by baseline hemoglobin (< median versus >=median) and geographic region (Asia/Other, North America, and Europe).

2. Primary Outcome

Title	Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Description	Adverse Event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Treatment emergent serious adverse events (TESAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, was medically important event. Treatment emergent adverse events (TEAEs): AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from first investigational medicinal product [IMP] administration in Part B to last IMP administration + 9 weeks follow-up period).
Time Frame	Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172)

Outcome Measure Data

Analysis Population Description

Analyzed on Part B safety analysis set (SAS) which included all participants who received at least 1 dose (including partial dose) of study drug in Part B. Data for this outcome measures was planned to be collected and analyzed separately for each dose of BIVV009 (6.5 g and 7.5 g).

Arm/Group Title	Part B: BIVV009 6.5 g	Part B: BIVV009 7.5 g
Arm/Group Description:	Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 149 weeks. Participants who received placebo in Part A received BIVV009 6.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 6.5 g in Part A received placebo on Week 26, BIVV009 6.5 g on Week 27 and every 2 weeks thereafter for up to an additional 149 weeks.	Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 137 weeks. Participants who received placebo in Part A received BIVV009 7.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 7.5 g in Part A received placebo on Week 26, BIVV009 7.5 g on Week 27 and every 2 weeks thereafter for up to an additional 137 weeks.
Overall Number of Participants Analyzed	32	7
Measure Type: Count of Participants; Unit of Measure: Participants
TEAEs	29 90.6%	7 100.0%
TESAEs	6 18.8%	1 14.3%

3. Secondary Outcome

Title	Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint
Description	Mean change from baseline (Week 0) in Hemoglobin (Hgb) at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Least squares (LS) mean and 95 % confidence interval (CI) was assessed by Mixed Model for Repeated Measures (MMRM) approach using heterogeneous Toeplitz (TOEPH) covariance matrix with change from baseline as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame	Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A.

Arm/Group Title	BIVV009	Placebo
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed	22	20
Least Squares Mean (95% Confidence Interval); Unit of Measure: grams per deciliter
	2.66; (2.09 to 3.22)	0.09; (-0.50 to 0.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BIVV009, Placebo
	Comments	A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Threshold of significance at 0.05 level.
	Method	Mixed model for repeated measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.56
	Confidence Interval	(2-Sided) 95%; 1.75 to 3.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.408
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint
Description	FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. Total score ranged from 0 to 52, with higher score indicating more fatigue. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. LS mean and 95% CI was assessed by MMRM approach using TOEPH covariance matrix with change from baseline (Week 0) as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame	Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A.

Arm/Group Title	BIVV009	Placebo
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed	22	20
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	10.83; (7.45 to 14.22)	1.91; (-1.65 to 5.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BIVV009, Placebo
	Comments	A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	Threshold of significance at 0.05 level.
	Method	Mixed model for repeated measures
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	8.93
	Confidence Interval	(2-Sided) 95%; 4.00 to 13.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.450
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint
Description	Mean change from baseline (Week 0) in total bilirubin at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame	Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A.

Arm/Group Title	BIVV009	Placebo
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed	19	20
Mean (Standard Deviation); Unit of Measure: micromoles per liter
	-22.881 (10.401)	-1.388 (13.901)

6. Secondary Outcome

Title	Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint
Description	Mean change from baseline (Week 0) in LDH at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame	Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A.

Arm/Group Title	BIVV009	Placebo
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed	19	20
Mean (Standard Deviation); Unit of Measure: units per liter
	-150.833 (160.824)	7.600 (212.690)

7. Secondary Outcome

Title	Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26
Description	Symptomatic anemia was defined as having following symptoms: i. Fatigue; ii. Weakness; iii. Shortness of breath; iv. Palpitations, fast heartbeat; v. Light headedness and/or vi. Chest pain. Percentage of participants with solicited symptomatic anemia symptoms was reported in this outcome measure.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A.

Arm/Group Title	BIVV009	Placebo
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed	19	19
Measure Type: Number; Unit of Measure: percentage of participants
Fatigue	31.6	68.4
Weakness	5.3	31.6
Shortness of breath	5.3	36.8
Palpitations	0	15.8
Light headedness	5.3	15.8
Chest pain	0	5.3

8. Secondary Outcome

Title	Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points
Description	Change from baseline (Week 0) in Hgb levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43,45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83,85,87, 89,91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147,149,151,153, 155,157,159,161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. Early Termination (ET) visit/safety follow up (SFU) visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints.
Time Frame	Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analyzed on Part B-FAS which included all participants who enrolled in Part B and received at least 1 dose (including partial dose) of study drug (BIVV009). Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Mean (Standard Deviation); Unit of Measure: grams per deciliter
Week 27	Number Analyzed	19 participants	20 participants
		2.647 (1.348)	1.125 (1.545)
Week 29	Number Analyzed	17 participants	18 participants
		2.507 (1.669)	1.947 (1.467)
Week 31	Number Analyzed	18 participants	19 participants
		2.490 (1.550)	2.358 (1.471)
Week 33	Number Analyzed	18 participants	19 participants
		2.519 (1.520)	1.987 (2.054)
Week 35	Number Analyzed	17 participants	19 participants
		2.611 (1.522)	1.977 (2.010)
Week 37	Number Analyzed	18 participants	19 participants
		2.197 (1.461)	2.469 (1.550)
Week 39	Number Analyzed	17 participants	18 participants
		2.528 (1.607)	2.368 (1.835)
Week 41	Number Analyzed	19 participants	19 participants
		2.162 (1.636)	2.074 (1.825)
Week 43	Number Analyzed	17 participants	19 participants
		2.436 (1.103)	2.182 (1.643)
Week 45	Number Analyzed	18 participants	20 participants
		2.644 (1.688)	2.249 (1.858)
Week 47	Number Analyzed	16 participants	19 participants
		2.335 (1.108)	2.315 (2.129)
Week 49	Number Analyzed	16 participants	18 participants
		2.531 (1.280)	2.121 (1.883)
Week 51	Number Analyzed	16 participants	19 participants
		2.349 (1.260)	2.394 (1.870)
Week 53	Number Analyzed	16 participants	18 participants
		2.346 (1.182)	2.411 (1.786)
Week 55	Number Analyzed	17 participants	18 participants
		2.438 (1.396)	2.539 (1.403)
Week 57	Number Analyzed	16 participants	17 participants
		2.531 (1.446)	2.250 (1.774)
Week 59	Number Analyzed	17 participants	17 participants
		2.590 (1.397)	2.008 (2.615)
Week 61	Number Analyzed	17 participants	18 participants
		4.073 (6.761)	2.059 (1.911)
Week 63	Number Analyzed	17 participants	17 participants
		2.382 (1.546)	2.102 (1.780)
Week 65	Number Analyzed	16 participants	17 participants
		2.925 (1.447)	2.311 (1.986)
Week 67	Number Analyzed	17 participants	17 participants
		4.170 (6.509)	2.534 (2.036)
Week 69	Number Analyzed	16 participants	17 participants
		2.777 (1.411)	2.505 (2.093)
Week 71	Number Analyzed	14 participants	15 participants
		2.654 (1.495)	2.357 (1.758)
Week 73	Number Analyzed	15 participants	16 participants
		2.800 (2.132)	2.197 (1.989)
Week 75	Number Analyzed	15 participants	16 participants
		2.391 (1.700)	2.175 (2.151)
Week 77	Number Analyzed	14 participants	16 participants
		3.074 (2.088)	2.451 (1.878)
Week 79	Number Analyzed	13 participants	15 participants
		2.614 (1.874)	2.419 (2.247)
Week 81	Number Analyzed	14 participants	17 participants
		2.598 (1.801)	2.458 (1.579)
Week 83	Number Analyzed	14 participants	13 participants
		2.469 (1.777)	2.762 (1.539)
Week 85	Number Analyzed	12 participants	15 participants
		2.755 (1.942)	2.489 (1.375)
Week 87	Number Analyzed	13 participants	15 participants
		2.477 (1.779)	2.765 (1.605)
Week 89	Number Analyzed	12 participants	13 participants
		2.551 (1.835)	2.482 (2.004)
Week 91	Number Analyzed	11 participants	12 participants
		2.380 (2.084)	2.556 (1.538)
Week 93	Number Analyzed	11 participants	12 participants
		2.931 (2.386)	2.655 (2.033)
Week 95	Number Analyzed	11 participants	12 participants
		2.262 (2.014)	2.578 (1.970)
Week 97	Number Analyzed	11 participants	12 participants
		2.413 (2.262)	2.551 (1.544)
Week 99	Number Analyzed	11 participants	13 participants
		2.019 (1.799)	2.412 (1.822)
Week 101	Number Analyzed	11 participants	12 participants
		2.276 (1.986)	2.171 (1.852)
Week 103	Number Analyzed	11 participants	13 participants
		2.378 (2.342)	2.527 (1.807)
Week 105	Number Analyzed	11 participants	12 participants
		2.291 (1.719)	2.321 (1.805)
Week 107	Number Analyzed	11 participants	13 participants
		2.319 (1.511)	2.560 (1.858)
Week 109	Number Analyzed	11 participants	11 participants
		2.509 (1.772)	2.645 (1.608)
Week 111	Number Analyzed	11 participants	12 participants
		2.416 (1.908)	2.750 (1.707)
Week 113	Number Analyzed	11 participants	12 participants
		2.860 (1.832)	2.268 (1.497)
Week 115	Number Analyzed	10 participants	10 participants
		2.622 (1.986)	2.326 (1.809)
Week 117	Number Analyzed	9 participants	11 participants
		3.135 (1.598)	2.474 (1.808)
Week 119	Number Analyzed	9 participants	10 participants
		3.106 (1.493)	2.608 (2.045)
Week 121	Number Analyzed	9 participants	8 participants
		3.388 (1.616)	2.325 (2.223)
Week 123	Number Analyzed	9 participants	9 participants
		3.255 (1.346)	2.878 (2.667)
Week 125	Number Analyzed	8 participants	7 participants
		3.197 (1.366)	1.700 (2.684)
Week 127	Number Analyzed	7 participants	8 participants
		3.371 (1.551)	2.102 (3.211)
Week 129	Number Analyzed	7 participants	7 participants
		3.171 (1.566)	2.129 (2.739)
Week 131	Number Analyzed	6 participants	6 participants
		3.453 (1.823)	1.423 (3.184)
Week 133	Number Analyzed	5 participants	4 participants
		3.520 (1.707)	2.025 (1.167)
Week 135	Number Analyzed	5 participants	5 participants
		3.611 (1.458)	3.048 (1.620)
Week 137	Number Analyzed	4 participants	3 participants
		4.074 (2.392)	2.400 (1.808)
Week 139	Number Analyzed	5 participants	3 participants
		3.929 (1.889)	3.334 (2.669)
Week 141	Number Analyzed	3 participants	3 participants
		3.500 (0.656)	2.733 (1.674)
Week 143	Number Analyzed	4 participants	3 participants
		3.220 (1.064)	2.985 (1.904)
Week 145	Number Analyzed	2 participants	3 participants
		3.350 (0.636)	3.467 (2.108)
Week 147	Number Analyzed	3 participants	2 participants
		3.202 (0.591)	2.300 (0.566)
Week 149	Number Analyzed	1 participants	2 participants
		2.900	2.550 (0.778)
Week 151	Number Analyzed	2 participants	1 participants
		2.961 (0.370)	3.000
Week 153	Number Analyzed	1 participants	1 participants
		2.800	2.800
Week 155	Number Analyzed	1 participants	1 participants
		2.700	3.600
Week 157	Number Analyzed	1 participants	1 participants
		2.700	3.000
Week 159	Number Analyzed	1 participants	1 participants
		3.300	2.300
Week 161	Number Analyzed	1 participants	1 participants
		4.100	2.400
Week 163	Number Analyzed	1 participants	1 participants
		4.100	2.600
Week 165	Number Analyzed	1 participants	0 participants
		3.800
Week 167	Number Analyzed	1 participants	0 participants
		4.700
Week 169	Number Analyzed	1 participants	0 participants
		4.300
Week 171	Number Analyzed	1 participants	0 participants
		4.200
Week 173	Number Analyzed	1 participants	0 participants
		4.000
Week 175	Number Analyzed	1 participants	0 participants
		2.500
ET/SFU Visit	Number Analyzed	17 participants	18 participants
		0.149 (2.073)	0.359 (1.872)

9. Secondary Outcome

Title	Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points
Description	Change from baseline (Week 0) in total bilirubin levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65,67,69,71,73,75, 77, 79, 81,83, 85, 87, 89, 91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121, 123, 125, 127,129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints.
Time Frame	Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'overall number of participants analyzed'=participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		17	18
Mean (Standard Deviation); Unit of Measure: micromoles per liter
Week 27	Number Analyzed	17 participants	18 participants
		-22.965 (9.899)	-18.761 (13.353)
Week 29	Number Analyzed	16 participants	18 participants
		-20.119 (12.170)	-19.889 (14.500)
Week 31	Number Analyzed	16 participants	17 participants
		-21.675 (11.025)	-22.153 (14.962)
Week 33	Number Analyzed	15 participants	16 participants
		-19.860 (11.527)	-24.263 (15.169)
Week 35	Number Analyzed	15 participants	16 participants
		-20.540 (10.557)	-21.888 (13.930)
Week 37	Number Analyzed	16 participants	15 participants
		-21.350 (13.234)	-22.527 (16.315)
Week 39	Number Analyzed	15 participants	15 participants
		-23.493 (11.425)	-21.173 (15.901)
Week 41	Number Analyzed	16 participants	16 participants
		-18.694 (12.189)	-21.138 (16.150)
Week 43	Number Analyzed	15 participants	16 participants
		-20.593 (11.449)	-21.544 (16.603)
Week 45	Number Analyzed	16 participants	18 participants
		-18.556 (11.213)	-20.156 (16.757)
Week 47	Number Analyzed	14 participants	18 participants
		-20.400 (9.803)	-20.250 (15.536)
Week 49	Number Analyzed	14 participants	17 participants
		-21.450 (10.271)	-21.024 (13.630)
Week 51	Number Analyzed	14 participants	16 participants
		-19.686 (11.072)	-19.444 (15.942)
Week 53	Number Analyzed	15 participants	17 participants
		-19.107 (11.267)	-20.335 (17.126)
Week 55	Number Analyzed	13 participants	16 participants
		-19.354 (12.209)	-23.481 (12.300)
Week 57	Number Analyzed	13 participants	15 participants
		-21.708 (10.467)	-18.953 (15.825)
Week 59	Number Analyzed	14 participants	15 participants
		-19.979 (9.706)	-19.820 (16.209)
Week 61	Number Analyzed	13 participants	15 participants
		-18.254 (10.541)	-21.073 (17.457)
Week 63	Number Analyzed	15 participants	15 participants
		-21.587 (9.680)	-21.753 (16.663)
Week 65	Number Analyzed	14 participants	14 participants
		-20.400 (9.866)	-20.950 (19.833)
Week 67	Number Analyzed	15 participants	14 participants
		-22.680 (10.317)	-20.150 (20.250)
Week 69	Number Analyzed	14 participants	15 participants
		-21.279 (9.423)	-17.827 (22.194)
Week 71	Number Analyzed	12 participants	13 participants
		-19.008 (8.255)	-20.585 (21.125)
Week 73	Number Analyzed	12 participants	15 participants
		-23.058 (7.766)	-20.080 (17.803)
Week 75	Number Analyzed	12 participants	14 participants
		-21.492 (7.453)	-20.771 (20.261)
Week 77	Number Analyzed	12 participants	14 participants
		-23.267 (8.972)	-19.814 (19.337)
Week 79	Number Analyzed	12 participants	15 participants
		-21.125 (12.701)	-21.027 (19.830)
Week 81	Number Analyzed	11 participants	13 participants
		-19.255 (9.478)	-22.331 (20.117)
Week 83	Number Analyzed	12 participants	11 participants
		-16.567 (12.565)	-25.091 (13.838)
Week 85	Number Analyzed	11 participants	13 participants
		-18.045 (12.183)	-23.292 (12.976)
Week 87	Number Analyzed	10 participants	11 participants
		-19.990 (12.043)	-21.473 (14.444)
Week 89	Number Analyzed	10 participants	11 participants
		-17.790 (11.036)	-24.782 (13.390)
Week 91	Number Analyzed	9 participants	11 participants
		-16.944 (13.476)	-23.091 (14.949)
Week 93	Number Analyzed	9 participants	10 participants
		-18.300 (11.132)	-24.970 (13.852)
Week 95	Number Analyzed	8 participants	11 participants
		-18.613 (12.265)	-23.564 (11.122)
Week 97	Number Analyzed	9 participants	9 participants
		-18.656 (11.462)	-26.122 (11.870)
Week 99	Number Analyzed	9 participants	11 participants
		-17.389 (10.932)	-23.700 (12.919)
Week 101	Number Analyzed	9 participants	10 participants
		-18.411 (10.175)	-25.940 (12.309)
Week 103	Number Analyzed	9 participants	11 participants
		-18.178 (11.156)	-22.655 (11.308)
Week 105	Number Analyzed	9 participants	10 participants
		-19.422 (8.444)	-26.920 (10.996)
Week 107	Number Analyzed	9 participants	11 participants
		-18.100 (9.955)	-23.018 (12.755)
Week 109	Number Analyzed	9 participants	9 participants
		-18.456 (10.606)	-25.422 (14.100)
Week 111	Number Analyzed	9 participants	10 participants
		-19.767 (9.992)	-24.380 (12.298)
Week 113	Number Analyzed	9 participants	10 participants
		-19.389 (9.192)	-23.940 (15.514)
Week 115	Number Analyzed	9 participants	9 participants
		-19.622 (8.194)	-21.533 (14.215)
Week 117	Number Analyzed	8 participants	8 participants
		-22.088 (10.247)	-22.225 (15.256)
Week 119	Number Analyzed	8 participants	8 participants
		-20.038 (8.529)	-22.713 (14.859)
Week 121	Number Analyzed	8 participants	6 participants
		-22.063 (7.215)	-21.183 (10.750)
Week 123	Number Analyzed	8 participants	7 participants
		-21.438 (8.058)	-22.029 (12.421)
Week 125	Number Analyzed	7 participants	5 participants
		-20.657 (8.889)	-19.560 (12.997)
Week 127	Number Analyzed	6 participants	6 participants
		-20.550 (9.782)	-21.433 (15.850)
Week 129	Number Analyzed	6 participants	5 participants
		-22.883 (11.291)	-19.020 (11.749)
Week 131	Number Analyzed	5 participants	5 participants
		-19.420 (12.936)	-23.100 (15.797)
Week 133	Number Analyzed	4 participants	4 participants
		-27.600 (7.477)	-17.450 (16.917)
Week 135	Number Analyzed	4 participants	5 participants
		-29.500 (7.816)	-21.900 (19.552)
Week 137	Number Analyzed	3 participants	2 participants
		-28.833 (8.615)	-11.650 (18.173)
Week 139	Number Analyzed	4 participants	3 participants
		-25.800 (9.081)	-24.733 (17.470)
Week 141	Number Analyzed	2 participants	3 participants
		-34.400 (2.404)	-13.833 (16.669)
Week 143	Number Analyzed	3 participants	3 participants
		-26.967 (9.235)	-20.033 (22.861)
Week 145	Number Analyzed	2 participants	3 participants
		-32.900 (3.677)	-18.100 (27.217)
Week 147	Number Analyzed	3 participants	2 participants
		-29.300 (7.418)	-3.300 (34.083)
Week 149	Number Analyzed	1 participants	2 participants
		-31.700	-7.300 (28.284)
Week 151	Number Analyzed	2 participants	1 participants
		-21.500 (0.566)	0.300
Week 153	Number Analyzed	1 participants	1 participants
		-30.800	-11.400
Week 155	Number Analyzed	1 participants	1 participants
		-35.300	0.700
Week 157	Number Analyzed	1 participants	1 participants
		-32.400	-0.100
Week 159	Number Analyzed	1 participants	1 participants
		-32.500	4.700
Week 161	Number Analyzed	1 participants	1 participants
		-36.800	5.500
Week 163	Number Analyzed	1 participants	1 participants
		-37.100	13.000
Week 165	Number Analyzed	1 participants	0 participants
		-36.300
Week 167	Number Analyzed	1 participants	0 participants
		-34.300
Week 169	Number Analyzed	1 participants	0 participants
		-32.700
Week 171	Number Analyzed	1 participants	0 participants
		-33.100
Week 173	Number Analyzed	1 participants	0 participants
		-32.100
Week 175	Number Analyzed	1 participants	0 participants
		-28.400
ET/SFU Visit	Number Analyzed	17 participants	17 participants
		1.976 (9.444)	1.165 (18.773)

10. Secondary Outcome

Title	Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points
Description	FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. The Total score ranged from 0 to 52, with higher score indicating more fatigue. Baseline (Week 0) was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame	Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 39	Number Analyzed	18 participants	18 participants
		11.048 (12.333)	7.958 (12.003)
Week 51	Number Analyzed	15 participants	16 participants
		10.080 (11.506)	6.354 (9.680)
Week 63	Number Analyzed	16 participants	16 participants
		10.672 (13.225)	8.499 (11.146)
Week 75	Number Analyzed	13 participants	14 participants
		9.861 (12.953)	10.304 (9.722)
Week 87	Number Analyzed	13 participants	15 participants
		11.015 (13.972)	8.483 (11.323)
Week 99	Number Analyzed	11 participants	13 participants
		12.109 (14.786)	8.788 (10.985)
Week 111	Number Analyzed	11 participants	12 participants
		11.563 (13.411)	10.688 (11.768)
Week 123	Number Analyzed	9 participants	9 participants
		10.806 (13.736)	6.583 (16.613)
Week 135	Number Analyzed	5 participants	5 participants
		16.683 (18.953)	12.650 (15.243)
Week 147	Number Analyzed	2 participants	2 participants
		9.208 (1.120)	0.500 (2.121)
Week 159	Number Analyzed	1 participants	1 participants
		20.000	10.000
Week 171	Number Analyzed	1 participants	0 participants
		15.000
ET/SFU Visit	Number Analyzed	19 participants	18 participants
		-1.257 (10.399)	-1.551 (12.840)

11. Secondary Outcome

Title	Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points
Description	SF-12: 12 item-questionnaire assessed health-related quality of life (HRQOL), contained 12 items, categorized into 8 domains (subscales) of functioning and well-being: physical functioning, role-physical, role emotional, mental health, bodily pain, general health, vitality and social functioning, with each domain score ranged from 0 (poor health) to 100 (better health). Higher scores = good health condition. These 8 domains were further summarized into 2 summary scores, PCS and MCS that ranged from 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame	Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 39-PCS	Number Analyzed	18 participants	18 participants
		4.814 (8.830)	6.745 (11.255)
Week 39-MCS	Number Analyzed	18 participants	18 participants
		8.543 (9.155)	1.151 (11.591)
Week 51-PCS	Number Analyzed	14 participants	16 participants
		5.320 (6.913)	5.654 (8.527)
Week 51-MCS	Number Analyzed	14 participants	16 participants
		8.461 (6.754)	1.704 (8.813)
Week 63-PCS	Number Analyzed	16 participants	16 participants
		5.840 (6.916)	6.216 (9.514)
Week 63-MCS	Number Analyzed	16 participants	16 participants
		8.117 (9.955)	1.722 (10.175)
Week 75-PCS	Number Analyzed	12 participants	15 participants
		5.723 (7.563)	7.661 (10.418)
Week 75-MCS	Number Analyzed	12 participants	15 participants
		7.932 (9.279)	3.519 (7.891)
Week 87-PCS	Number Analyzed	12 participants	15 participants
		5.226 (8.196)	8.778 (12.405)
Week 87-MCS	Number Analyzed	12 participants	15 participants
		6.058 (10.981)	2.219 (9.111)
Week 99-PCS	Number Analyzed	10 participants	13 participants
		3.945 (7.463)	8.262 (12.534)
Week 99-MCS	Number Analyzed	10 participants	13 participants
		7.136 (11.850)	4.682 (7.698)
Week 111-PCS	Number Analyzed	10 participants	12 participants
		4.800 (7.985)	8.080 (12.302)
Week 111-MCS	Number Analyzed	10 participants	12 participants
		8.705 (7.777)	4.411 (10.249)
Week 123-PCS	Number Analyzed	9 participants	9 participants
		4.147 (7.110)	7.973 (13.200)
Week 123-MCS	Number Analyzed	9 participants	9 participants
		8.650 (8.323)	-2.538 (13.136)
Week 135-PCS	Number Analyzed	5 participants	4 participants
		6.660 (9.096)	6.070 (13.819)
Week 135-MCS	Number Analyzed	5 participants	4 participants
		8.860 (9.817)	2.790 (6.170)
Week 147-PCS	Number Analyzed	2 participants	2 participants
		-1.655 (3.769)	-3.740 (1.824)
Week 147-MCS	Number Analyzed	2 participants	2 participants
		11.220 (6.095)	-1.110 (0.679)
Week 159-PCS	Number Analyzed	1 participants	1 participants
		5.620	-10.410
Week 159-MCS	Number Analyzed	1 participants	1 participants
		16.400	9.590
Week 171-PCS	Number Analyzed	1 participants	0 participants
		11.980
Week 171-MCS	Number Analyzed	1 participants	0 participants
		0.250
ET/SFU Visit-PCS	Number Analyzed	18 participants	18 participants
		-3.478 (10.875)	-0.429 (10.922)
ET/SFU Visit-MCS	Number Analyzed	18 participants	18 participants
		1.835 (11.882)	-2.137 (10.148)

12. Secondary Outcome

Title	Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points
Description	EQ-5D-5L included 2 components: health state utility index (descriptive system) and Visual Analog Scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response option: no problem, slight problem, moderate problem, severe problem and extreme problems measured with Likert scale. EQ-5D-5L responses converted into single index utility score between 0 to 1. Higher score=better health. EQ-5D-5L VAS rated participant's current health state on scale from 0 (worst imaginable health) to 100 (best imaginable health). Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame	Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 39-Index score	Number Analyzed	17 participants	18 participants
		0.020 (0.165)	0.054 (0.135)
Week 51-Index score	Number Analyzed	15 participants	16 participants
		0.075 (0.173)	-0.008 (0.197)
Week 63-Index score	Number Analyzed	16 participants	16 participants
		0.060 (0.214)	0.015 (0.157)
Week 75-Index score	Number Analyzed	13 participants	15 participants
		-0.004 (0.144)	0.063 (0.152)
Week 87-Index score	Number Analyzed	13 participants	15 participants
		-0.034 (0.240)	0.059 (0.158)
Week 99-Index score	Number Analyzed	11 participants	13 participants
		-0.058 (0.216)	0.058 (0.146)
Week 111-Index score	Number Analyzed	11 participants	12 participants
		-0.033 (0.205)	0.050 (0.194)
Week 123-Index score	Number Analyzed	9 participants	9 participants
		-0.020 (0.235)	0.031 (0.221)
Week 135-Index score	Number Analyzed	5 participants	5 participants
		0.008 (0.351)	0.094 (0.245)
Week 147-Index score	Number Analyzed	2 participants	2 participants
		0.054 (0.037)	-0.087 (0.222)
Week 159-Index score	Number Analyzed	1 participants	1 participants
		0.174	0.087
Week 171-Index score	Number Analyzed	1 participants	0 participants
		0.053
ET/SFU Visit-Index score	Number Analyzed	19 participants	18 participants
		-0.108 (0.238)	-0.077 (0.169)
Week 39-VAS	Number Analyzed	17 participants	18 participants
		20.647 (16.871)	12.000 (17.146)
Week 51-VAS	Number Analyzed	15 participants	16 participants
		14.800 (27.589)	9.125 (21.112)
Week 63-VAS	Number Analyzed	15 participants	16 participants
		19.867 (21.603)	14.375 (15.573)
Week 75-VAS	Number Analyzed	13 participants	15 participants
		16.846 (22.120)	18.933 (20.243)
Week 87-VAS	Number Analyzed	13 participants	15 participants
		14.077 (25.221)	16.867 (17.912)
Week 99-VAS	Number Analyzed	11 participants	13 participants
		19.364 (20.796)	18.385 (20.706)
Week 111-VAS	Number Analyzed	11 participants	12 participants
		18.273 (19.463)	22.833 (20.621)
Week 123-VAS	Number Analyzed	9 participants	9 participants
		21.667 (18.371)	18.000 (30.389)
Week 135-VAS	Number Analyzed	5 participants	5 participants
		26.000 (20.433)	23.400 (27.574)
Week 147-VAS	Number Analyzed	2 participants	2 participants
		17.500 (17.678)	3.500 (26.163)
Week 159-VAS	Number Analyzed	1 participants	1 participants
		40.000	27.000
Week 171-VAS	Number Analyzed	1 participants	0 participants
		35.000
ET/SFU Visit-VAS	Number Analyzed	19 participants	18 participants
		1.526 (17.976)	-2.056 (14.957)

13. Secondary Outcome

Title	Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points
Description	The PGIS is a self-reported scale. The PGIS is a 1-item questionnaire designed to assess participant's impression of disease severity using a 5-point scale ranging from 1 to 5, where 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame	Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Measure Type: Count of Participants; Unit of Measure: Participants
Week 39 - None	Number Analyzed	17 participants	17 participants
		7 41.2%	5 29.4%
Week 39 - Mild	Number Analyzed	17 participants	17 participants
		8 47.1%	7 41.2%
Week 39 - Moderate	Number Analyzed	17 participants	17 participants
		1 5.9%	5 29.4%
Week 39 - Severe	Number Analyzed	17 participants	17 participants
		1 5.9%	0 0.0%
Week 39 - Very Severe	Number Analyzed	17 participants	17 participants
		0 0.0%	0 0.0%
Week 51 - None	Number Analyzed	15 participants	16 participants
		5 33.3%	4 25.0%
Week 51 - Mild	Number Analyzed	15 participants	16 participants
		8 53.3%	7 43.8%
Week 51 - Moderate	Number Analyzed	15 participants	16 participants
		2 13.3%	5 31.3%
Week 51 - Severe	Number Analyzed	15 participants	16 participants
		0 0.0%	0 0.0%
Week 51 - Very Severe	Number Analyzed	15 participants	16 participants
		0 0.0%	0 0.0%
Week 63 - None	Number Analyzed	17 participants	16 participants
		6 35.3%	4 25.0%
Week 63 - Mild	Number Analyzed	17 participants	16 participants
		8 47.1%	7 43.8%
Week 63 - Moderate	Number Analyzed	17 participants	16 participants
		3 17.6%	5 31.3%
Week 63 - Severe	Number Analyzed	17 participants	16 participants
		0 0.0%	0 0.0%
Week 63 - Very Severe	Number Analyzed	17 participants	16 participants
		0 0.0%	0 0.0%
Week 75 - None	Number Analyzed	13 participants	15 participants
		5 38.5%	6 40.0%
Week 75 - Mild	Number Analyzed	13 participants	15 participants
		6 46.2%	6 40.0%
Week 75 - Moderate	Number Analyzed	13 participants	15 participants
		2 15.4%	3 20.0%
Week 75 - Severe	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 75 - Very Severe	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 87 - None	Number Analyzed	13 participants	15 participants
		6 46.2%	7 46.7%
Week 87 - Mild	Number Analyzed	13 participants	15 participants
		5 38.5%	4 26.7%
Week 87 - Moderate	Number Analyzed	13 participants	15 participants
		1 7.7%	3 20.0%
Week 87 - Severe	Number Analyzed	13 participants	15 participants
		1 7.7%	1 6.7%
Week 87 - Very Severe	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 99 - None	Number Analyzed	11 participants	13 participants
		5 45.5%	8 61.5%
Week 99 - Mild	Number Analyzed	11 participants	13 participants
		5 45.5%	3 23.1%
Week 99 - Moderate	Number Analyzed	11 participants	13 participants
		1 9.1%	2 15.4%
Week 99 - Severe	Number Analyzed	11 participants	13 participants
		0 0.0%	0 0.0%
Week 99 - Very Severe	Number Analyzed	11 participants	13 participants
		0 0.0%	0 0.0%
Week 111 - None	Number Analyzed	11 participants	12 participants
		5 45.5%	7 58.3%
Week 111 - Mild	Number Analyzed	11 participants	12 participants
		4 36.4%	3 25.0%
Week 111 - Moderate	Number Analyzed	11 participants	12 participants
		2 18.2%	2 16.7%
Week 111 - Severe	Number Analyzed	11 participants	12 participants
		0 0.0%	0 0.0%
Week 111 - Very Severe	Number Analyzed	11 participants	12 participants
		0 0.0%	0 0.0%
Week 123 - None	Number Analyzed	9 participants	9 participants
		2 22.2%	5 55.6%
Week 123 - Mild	Number Analyzed	9 participants	9 participants
		6 66.7%	2 22.2%
Week 123 - Moderate	Number Analyzed	9 participants	9 participants
		1 11.1%	2 22.2%
Week 123 - Severe	Number Analyzed	9 participants	9 participants
		0 0.0%	0 0.0%
Week 123 - Very Severe	Number Analyzed	9 participants	9 participants
		0 0.0%	0 0.0%
Week 135 - None	Number Analyzed	5 participants	5 participants
		0 0.0%	2 40.0%
Week 135 - Mild	Number Analyzed	5 participants	5 participants
		3 60.0%	1 20.0%
Week 135 - Moderate	Number Analyzed	5 participants	5 participants
		2 40.0%	2 40.0%
Week 135 - Severe	Number Analyzed	5 participants	5 participants
		0 0.0%	0 0.0%
Week 135 - Very Severe	Number Analyzed	5 participants	5 participants
		0 0.0%	0 0.0%
Week 147 - None	Number Analyzed	2 participants	2 participants
		0 0.0%	1 50.0%
Week 147 - Mild	Number Analyzed	2 participants	2 participants
		1 50.0%	0 0.0%
Week 147 - Moderate	Number Analyzed	2 participants	2 participants
		1 50.0%	1 50.0%
Week 147 - Severe	Number Analyzed	2 participants	2 participants
		0 0.0%	0 0.0%
Week 147 - Very Severe	Number Analyzed	2 participants	2 participants
		0 0.0%	0 0.0%
Week 159 - None	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Mild	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Moderate	Number Analyzed	1 participants	1 participants
		1 100.0%	1 100.0%
Week 159 - Severe	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Very Severe	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 171 - None	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171 - Mild	Number Analyzed	1 participants	0 participants
		1 100.0%	0
Week 171 - Moderate	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171 - Severe	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171 - Very Severe	Number Analyzed	1 participants	0 participants
		0 0.0%	0
ET/SFU - None	Number Analyzed	19 participants	18 participants
		2 10.5%	4 22.2%
ET/SFU - Mild	Number Analyzed	19 participants	18 participants
		5 26.3%	3 16.7%
ET/SFU - Moderate	Number Analyzed	19 participants	18 participants
		7 36.8%	5 27.8%
ET/SFU - Severe	Number Analyzed	19 participants	18 participants
		3 15.8%	5 27.8%
ET/SFU - Very Severe	Number Analyzed	19 participants	18 participants
		2 10.5%	1 5.6%

14. Secondary Outcome

Title	Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points
Description	PGIC is a self-administered questionnaire to evaluate the improvement or worsening compared to the start of the study. PGIC was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGIC scores as follows: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worsen. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame	Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Measure Type: Count of Participants; Unit of Measure: Participants
Week 39 - Very much improved	Number Analyzed	17 participants	16 participants
		4 23.5%	3 18.8%
Week 39 - Much improved	Number Analyzed	17 participants	16 participants
		8 47.1%	6 37.5%
Week 39 - Minimally improved	Number Analyzed	17 participants	16 participants
		2 11.8%	6 37.5%
Week 39 - No Change	Number Analyzed	17 participants	16 participants
		2 11.8%	1 6.3%
Week 39 - Minimally worse	Number Analyzed	17 participants	16 participants
		1 5.9%	0 0.0%
Week 39 - Much worse	Number Analyzed	17 participants	16 participants
		0 0.0%	0 0.0%
Week 39 - Very much worse	Number Analyzed	17 participants	16 participants
		0 0.0%	0 0.0%
Week 51 - Very much improved	Number Analyzed	15 participants	16 participants
		5 33.3%	3 18.8%
Week 51 - Much improved	Number Analyzed	15 participants	16 participants
		3 20.0%	6 37.5%
Week 51 - Minimally improved	Number Analyzed	15 participants	16 participants
		2 13.3%	4 25.0%
Week 51 - No Change	Number Analyzed	15 participants	16 participants
		5 33.3%	2 12.5%
Week 51 - Minimally worse	Number Analyzed	15 participants	16 participants
		0 0.0%	0 0.0%
Week 51 - Much worse	Number Analyzed	15 participants	16 participants
		0 0.0%	1 6.3%
Week 51 - Very much worse	Number Analyzed	15 participants	16 participants
		0 0.0%	0 0.0%
Week 63 - Very much improved	Number Analyzed	17 participants	16 participants
		5 29.4%	3 18.8%
Week 63 - Much improved	Number Analyzed	17 participants	16 participants
		8 47.1%	4 25.0%
Week 63 - Minimally improved	Number Analyzed	17 participants	16 participants
		0 0.0%	5 31.3%
Week 63 - No change	Number Analyzed	17 participants	16 participants
		4 23.5%	3 18.8%
Week 63 - Minimally worse	Number Analyzed	17 participants	16 participants
		0 0.0%	0 0.0%
Week 63 - Much worse	Number Analyzed	17 participants	16 participants
		0 0.0%	1 6.3%
Week 63 - Very much worse	Number Analyzed	17 participants	16 participants
		0 0.0%	0 0.0%
Week 75 - Very much improved	Number Analyzed	13 participants	15 participants
		6 46.2%	6 40.0%
Week 75 - Much improved	Number Analyzed	13 participants	15 participants
		2 15.4%	3 20.0%
Week 75 - Minimally improved	Number Analyzed	13 participants	15 participants
		1 7.7%	5 33.3%
Week 75 - No Change	Number Analyzed	13 participants	15 participants
		4 30.8%	1 6.7%
Week 75 - Minimally worse	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 75 - Much worse	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 75 - Very much worse	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 87 - Very much improved	Number Analyzed	13 participants	15 participants
		7 53.8%	7 46.7%
Week 87 - Much improved	Number Analyzed	13 participants	15 participants
		0 0.0%	3 20.0%
Week 87 - Minimally improved	Number Analyzed	13 participants	15 participants
		2 15.4%	1 6.7%
Week 87 - No Change	Number Analyzed	13 participants	15 participants
		2 15.4%	3 20.0%
Week 87 - Minimally worse	Number Analyzed	13 participants	15 participants
		1 7.7%	1 6.7%
Week 87 - Much worse	Number Analyzed	13 participants	15 participants
		1 7.7%	0 0.0%
Week 87 - Very much worse	Number Analyzed	13 participants	15 participants
		0 0.0%	0 0.0%
Week 99 - Very much improved	Number Analyzed	11 participants	13 participants
		3 27.3%	8 61.5%
Week 99 - Much improved	Number Analyzed	11 participants	13 participants
		3 27.3%	2 15.4%
Week 99 - Minimally improved	Number Analyzed	11 participants	13 participants
		1 9.1%	3 23.1%
Week 99 - No change	Number Analyzed	11 participants	13 participants
		3 27.3%	0 0.0%
Week 99 - Minimally worse	Number Analyzed	11 participants	13 participants
		1 9.1%	0 0.0%
Week 99 - Much worse	Number Analyzed	11 participants	13 participants
		0 0.0%	0 0.0%
Week 99 - Very much worse	Number Analyzed	11 participants	13 participants
		0 0.0%	0 0.0%
Week 111 - Very much improved	Number Analyzed	11 participants	12 participants
		3 27.3%	6 50.0%
Week 111 - Much improved	Number Analyzed	11 participants	12 participants
		5 45.5%	4 33.3%
Week 111 - Minimally improved	Number Analyzed	11 participants	12 participants
		1 9.1%	1 8.3%
Week 111 - No Change	Number Analyzed	11 participants	12 participants
		2 18.2%	1 8.3%
Week 111 - Minimally worse	Number Analyzed	11 participants	12 participants
		0 0.0%	0 0.0%
Week 111 - Much worse	Number Analyzed	11 participants	12 participants
		0 0.0%	0 0.0%
Week 111 - Very much worse	Number Analyzed	11 participants	12 participants
		0 0.0%	0 0.0%
Week 123 - Very much improved	Number Analyzed	9 participants	9 participants
		3 33.3%	4 44.4%
Week 123 - Much improved	Number Analyzed	9 participants	9 participants
		3 33.3%	3 33.3%
Week 123 - Minimally improved	Number Analyzed	9 participants	9 participants
		2 22.2%	1 11.1%
Week 123 - No Change	Number Analyzed	9 participants	9 participants
		1 11.1%	1 11.1%
Week 123 - Minimally worse	Number Analyzed	9 participants	9 participants
		0 0.0%	0 0.0%
Week 123 - Much worse	Number Analyzed	9 participants	9 participants
		0 0.0%	0 0.0%
Week 123 - Very much worse	Number Analyzed	9 participants	9 participants
		0 0.0%	0 0.0%
Week 135 - Very much improved	Number Analyzed	5 participants	5 participants
		2 40.0%	2 40.0%
Week 135 - Much improved	Number Analyzed	5 participants	5 participants
		2 40.0%	1 20.0%
Week 135 - Minimally improved	Number Analyzed	5 participants	5 participants
		0 0.0%	1 20.0%
Week 135 - No Change	Number Analyzed	5 participants	5 participants
		0 0.0%	1 20.0%
Week 135 - Minimally worse	Number Analyzed	5 participants	5 participants
		1 20.0%	0 0.0%
Week 135 - Much worse	Number Analyzed	5 participants	5 participants
		0 0.0%	0 0.0%
Week 135 - Very much worse	Number Analyzed	5 participants	5 participants
		0 0.0%	0 0.0%
Week 147 - Very much improved	Number Analyzed	2 participants	2 participants
		1 50.0%	0 0.0%
Week 147 - Much improved	Number Analyzed	2 participants	2 participants
		0 0.0%	1 50.0%
Week 147 - Minimally improved	Number Analyzed	2 participants	2 participants
		0 0.0%	1 50.0%
Week 147 - No Change	Number Analyzed	2 participants	2 participants
		1 50.0%	0 0.0%
Week 147 - Minimally worse	Number Analyzed	2 participants	2 participants
		0 0.0%	0 0.0%
Week 147 - Much worse	Number Analyzed	2 participants	2 participants
		0 0.0%	0 0.0%
Week 147 - Very much worse	Number Analyzed	2 participants	2 participants
		0 0.0%	0 0.0%
Week 159 - Very much improved	Number Analyzed	1 participants	1 participants
		1 100.0%	0 0.0%
Week 159 - Much improved	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Minimally improved	Number Analyzed	1 participants	1 participants
		0 0.0%	1 100.0%
Week 159 - No Change	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Minimally worse	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Much worse	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 159 - Very much worse	Number Analyzed	1 participants	1 participants
		0 0.0%	0 0.0%
Week 171- Very much improved	Number Analyzed	1 participants	0 participants
		1 100.0%	0
Week 171- Much improved	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171- Minimally improved	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171- No Change	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171- Minimally worse	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171- Much worse	Number Analyzed	1 participants	0 participants
		0 0.0%	0
Week 171- Very much worse	Number Analyzed	1 participants	0 participants
		0 0.0%	0
ET/SFU Visit- Very much improved	Number Analyzed	19 participants	18 participants
		3 15.8%	3 16.7%
ET/SFU Visit- Much improved	Number Analyzed	19 participants	18 participants
		5 26.3%	6 33.3%
ET/SFU Visit- Minimally improved	Number Analyzed	19 participants	18 participants
		4 21.1%	1 5.6%
ET/SFU Visit- No Change	Number Analyzed	19 participants	18 participants
		3 15.8%	3 16.7%
ET/SFU Visit- Minimally worse	Number Analyzed	19 participants	18 participants
		1 5.3%	2 11.1%
ET/SFU Visit- Much worse	Number Analyzed	19 participants	18 participants
		3 15.8%	3 16.7%
ET/SFU Visit- Very much worse	Number Analyzed	19 participants	18 participants
		0 0.0%	0 0.0%

15. Secondary Outcome

Title	Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points
Description	Change from baseline (Week 0) in LDH levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 105, 107,109, 111, 113, 115, 117, 119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147, 149, 151,153,155,157,159,161,163,165,167,169, 171, 173, 175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame	Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Mean (Standard Deviation); Unit of Measure: units per liter
Week 27	Number Analyzed	19 participants	20 participants
		-151.000 (184.640)	0.650 (208.051)
Week 29	Number Analyzed	18 participants	19 participants
		-115.944 (226.913)	11.000 (222.383)
Week 31	Number Analyzed	18 participants	17 participants
		-85.111 (247.506)	38.882 (211.386)
Week 33	Number Analyzed	17 participants	16 participants
		-66.176 (324.145)	4.813 (203.939)
Week 35	Number Analyzed	18 participants	16 participants
		-64.667 (261.431)	-19.313 (142.989)
Week 37	Number Analyzed	16 participants	17 participants
		4.438 (398.843)	25.765 (219.679)
Week 39	Number Analyzed	16 participants	16 participants
		-88.500 (271.941)	27.313 (210.705)
Week 41	Number Analyzed	18 participants	17 participants
		23.778 (342.195)	-6.000 (173.810)
Week 43	Number Analyzed	17 participants	17 participants
		-22.118 (310.381)	-21.706 (181.668)
Week 45	Number Analyzed	17 participants	18 participants
		26.529 (329.717)	-13.500 (190.460)
Week 47	Number Analyzed	15 participants	18 participants
		-22.600 (302.511)	-24.944 (153.580)
Week 49	Number Analyzed	16 participants	18 participants
		-29.250 (289.392)	15.722 (193.630)
Week 51	Number Analyzed	16 participants	18 participants
		-12.563 (290.489)	-9.556 (155.646)
Week 53	Number Analyzed	16 participants	17 participants
		-16.938 (299.788)	12.529 (206.642)
Week 55	Number Analyzed	14 participants	16 participants
		-89.500 (219.634)	-11.250 (177.647)
Week 57	Number Analyzed	15 participants	16 participants
		-78.200 (285.140)	64.188 (266.395)
Week 59	Number Analyzed	16 participants	17 participants
		-84.438 (220.376)	31.647 (226.128)
Week 61	Number Analyzed	17 participants	17 participants
		-74.353 (215.414)	20.588 (263.984)
Week 63	Number Analyzed	17 participants	17 participants
		-98.235 (185.259)	38.059 (325.329)
Week 65	Number Analyzed	16 participants	15 participants
		-97.438 (212.335)	-16.467 (246.765)
Week 67	Number Analyzed	17 participants	15 participants
		-127.824 (192.148)	29.667 (269.918)
Week 69	Number Analyzed	16 participants	16 participants
		-113.625 (197.270)	36.563 (303.550)
Week 71	Number Analyzed	13 participants	15 participants
		-101.692 (320.348)	4.067 (307.924)
Week 73	Number Analyzed	14 participants	16 participants
		-174.500 (177.153)	7.063 (245.723)
Week 75	Number Analyzed	14 participants	15 participants
		-157.429 (184.525)	7.067 (285.183)
Week 77	Number Analyzed	14 participants	15 participants
		-142.857 (199.169)	-24.867 (291.754)
Week 79	Number Analyzed	13 participants	16 participants
		-98.077 (271.632)	-20.063 (265.761)
Week 81	Number Analyzed	13 participants	15 participants
		-127.846 (233.663)	7.200 (219.952)
Week 83	Number Analyzed	13 participants	11 participants
		-59.000 (346.917)	8.818 (250.068)
Week 85	Number Analyzed	13 participants	15 participants
		-72.000 (350.021)	28.400 (282.626)
Week 87	Number Analyzed	13 participants	13 participants
		-101.385 (285.590)	83.385 (288.731)
Week 89	Number Analyzed	12 participants	12 participants
		-78.667 (351.059)	10.833 (323.647)
Week 91	Number Analyzed	9 participants	13 participants
		-143.000 (273.540)	0.846 (288.451)
Week 93	Number Analyzed	10 participants	11 participants
		-133.500 (254.332)	10.818 (268.308)
Week 95	Number Analyzed	11 participants	13 participants
		-59.364 (368.708)	18.231 (241.354)
Week 97	Number Analyzed	11 participants	10 participants
		-53.364 (343.820)	-38.500 (188.403)
Week 99	Number Analyzed	11 participants	12 participants
		-80.909 (312.405)	-12.917 (183.844)
Week 101	Number Analyzed	11 participants	11 participants
		-90.273 (293.680)	-17.182 (249.134)
Week 103	Number Analyzed	11 participants	13 participants
		-50.273 (331.072)	5.692 (211.233)
Week 105	Number Analyzed	11 participants	12 participants
		-96.455 (276.907)	-34.250 (147.738)
Week 107	Number Analyzed	11 participants	13 participants
		-28.091 (354.244)	20.769 (222.772)
Week 109	Number Analyzed	11 participants	11 participants
		-50.727 (335.078)	-2.000 (243.243)
Week 111	Number Analyzed	10 participants	12 participants
		-83.000 (303.258)	-5.583 (219.850)
Week 113	Number Analyzed	10 participants	12 participants
		-80.700 (319.283)	0.667 (294.904)
Week 115	Number Analyzed	10 participants	10 participants
		-109.500 (256.395)	44.700 (295.946)
Week 117	Number Analyzed	9 participants	10 participants
		-140.444 (280.944)	12.700 (254.786)
Week 119	Number Analyzed	9 participants	10 participants
		-149.556 (237.771)	-26.500 (274.168)
Week 121	Number Analyzed	9 participants	8 participants
		-195.778 (225.978)	-42.375 (211.840)
Week 123	Number Analyzed	9 participants	9 participants
		-185.000 (231.489)	22.222 (278.037)
Week 125	Number Analyzed	7 participants	7 participants
		-99.429 (285.513)	-85.143 (265.374)
Week 127	Number Analyzed	7 participants	8 participants
		-154.714 (231.922)	-28.875 (312.483)
Week 129	Number Analyzed	7 participants	7 participants
		-136.429 (234.954)	-18.571 (354.584)
Week 131	Number Analyzed	6 participants	6 participants
		-120.833 (300.454)	-2.000 (270.245)
Week 133	Number Analyzed	5 participants	4 participants
		-179.000 (298.811)	-47.500 (367.639)
Week 135	Number Analyzed	5 participants	5 participants
		-211.800 (265.438)	58.000 (449.233)
Week 137	Number Analyzed	4 participants	2 participants
		-252.500 (264.591)	46.500 (768.625)
Week 139	Number Analyzed	5 participants	3 participants
		-181.800 (284.966)	-48.667 (373.339)
Week 141	Number Analyzed	3 participants	3 participants
		-259.667 (362.136)	30.667 (372.889)
Week 143	Number Analyzed	4 participants	2 participants
		-160.250 (357.021)	-7.500 (21.920)
Week 145	Number Analyzed	2 participants	2 participants
		-340.500 (458.912)	290.000 (562.857)
Week 147	Number Analyzed	3 participants	2 participants
		-248.667 (355.136)	311.000 (547.301)
Week 149	Number Analyzed	1 participants	2 participants
		-78.000	116.000 (175.362)
Week 151	Number Analyzed	2 participants	1 participants
		58.000 (32.527)	295.000
Week 153	Number Analyzed	1 participants	1 participants
		7.000	75.000
Week 155	Number Analyzed	1 participants	0 participants
		-50.000
Week 157	Number Analyzed	1 participants	1 participants
		-50.000	369.000
Week 159	Number Analyzed	1 participants	1 participants
		-155.000	365.000
Week 161	Number Analyzed	1 participants	0 participants
		-175.000
Week 163	Number Analyzed	1 participants	1 participants
		-149.000	782.000
Week 165	Number Analyzed	1 participants	0 participants
		-155.000
Week 167	Number Analyzed	1 participants	0 participants
		-162.000
Week 169	Number Analyzed	1 participants	0 participants
		-180.000
Week 171	Number Analyzed	1 participants	0 participants
		-167.000
Week 173	Number Analyzed	1 participants	0 participants
		-171.000
Week 175	Number Analyzed	1 participants	0 participants
		-121.000
ET/SFU Visit	Number Analyzed	16 participants	17 participants
		-2.500 (195.967)	-11.706 (206.321)

16. Secondary Outcome

Title	Part B: Number of Blood Transfusions Per Participant
Description	A participant was to receive a transfusion if his or her Hgb level met either of the following criteria: Hgb was <9 g/dL and the participant had symptoms of anemia or Hgb was <7 g/dL and the participant was asymptomatic.
Time Frame	From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title	BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed	19	20
Mean (Standard Deviation); Unit of Measure: blood transfusions per participant
	0.4 (0.8)	0.3 (0.4)

17. Secondary Outcome

Title	Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points
Description	Change from baseline (Week 0) in haptoglobin values at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97,99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127, 129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Haptoglobin values <0.2 were imputed as 0.2.
Time Frame	Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title		BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed		19	20
Mean (Standard Deviation); Unit of Measure: grams per liter
Week 27	Number Analyzed	19 participants	19 participants
		0.219 (0.380)	0.082 (0.197)
Week 29	Number Analyzed	18 participants	20 participants
		0.240 (0.317)	0.182 (0.482)
Week 31	Number Analyzed	19 participants	20 participants
		0.183 (0.311)	0.256 (0.516)
Week 33	Number Analyzed	19 participants	17 participants
		0.212 (0.423)	0.229 (0.379)
Week 35	Number Analyzed	18 participants	19 participants
		0.207 (0.355)	0.151 (0.280)
Week 37	Number Analyzed	18 participants	18 participants
		0.232 (0.419)	0.187 (0.291)
Week 39	Number Analyzed	16 participants	16 participants
		0.213 (0.330)	0.165 (0.295)
Week 41	Number Analyzed	19 participants	18 participants
		0.119 (0.238)	0.082 (0.168)
Week 43	Number Analyzed	18 participants	18 participants
		0.100 (0.224)	0.161 (0.234)
Week 45	Number Analyzed	18 participants	20 participants
		0.114 (0.205)	0.189 (0.275)
Week 47	Number Analyzed	15 participants	20 participants
		0.135 (0.243)	0.255 (0.416)
Week 49	Number Analyzed	16 participants	18 participants
		0.139 (0.205)	0.172 (0.345)
Week 51	Number Analyzed	15 participants	17 participants
		0.083 (0.197)	0.207 (0.369)
Week 53	Number Analyzed	16 participants	19 participants
		0.045 (0.137)	0.122 (0.296)
Week 55	Number Analyzed	17 participants	18 participants
		0.149 (0.251)	0.179 (0.343)
Week 57	Number Analyzed	16 participants	17 participants
		0.158 (0.234)	0.158 (0.362)
Week 59	Number Analyzed	17 participants	17 participants
		0.132 (0.229)	0.131 (0.306)
Week 61	Number Analyzed	17 participants	18 participants
		0.153 (0.286)	0.184 (0.350)
Week 63	Number Analyzed	17 participants	17 participants
		0.202 (0.265)	0.177 (0.357)
Week 65	Number Analyzed	16 participants	16 participants
		0.101 (0.232)	0.198 (0.384)
Week 67	Number Analyzed	17 participants	16 participants
		0.178 (0.241)	0.162 (0.363)
Week 69	Number Analyzed	16 participants	17 participants
		0.168 (0.255)	0.169 (0.348)
Week 71	Number Analyzed	14 participants	15 participants
		0.220 (0.288)	0.236 (0.388)
Week 73	Number Analyzed	14 participants	16 participants
		0.261 (0.335)	0.174 (0.348)
Week 75	Number Analyzed	15 participants	16 participants
		0.275 (0.321)	0.197 (0.362)
Week 77	Number Analyzed	14 participants	16 participants
		0.249 (0.374)	0.232 (0.398)
Week 79	Number Analyzed	14 participants	16 participants
		0.299 (0.419)	0.290 (0.464)
Week 81	Number Analyzed	13 participants	16 participants
		0.438 (0.463)	0.207 (0.421)
Week 83	Number Analyzed	14 participants	13 participants
		0.297 (0.379)	0.233 (0.394)
Week 85	Number Analyzed	13 participants	15 participants
		0.374 (0.374)	0.266 (0.426)
Week 87	Number Analyzed	12 participants	13 participants
		0.334 (0.409)	0.344 (0.471)
Week 89	Number Analyzed	12 participants	13 participants
		0.348 (0.482)	0.198 (0.351)
Week 91	Number Analyzed	11 participants	12 participants
		0.313 (0.449)	0.279 (0.449)
Week 93	Number Analyzed	11 participants	12 participants
		0.262 (0.383)	0.178 (0.373)
Week 95	Number Analyzed	11 participants	13 participants
		0.263 (0.495)	0.198 (0.414)
Week 97	Number Analyzed	11 participants	12 participants
		0.245 (0.306)	0.210 (0.407)
Week 99	Number Analyzed	11 participants	13 participants
		0.266 (0.351)	0.213 (0.370)
Week 101	Number Analyzed	11 participants	12 participants
		0.289 (0.289)	0.207 (0.417)
Week 103	Number Analyzed	11 participants	13 participants
		0.219 (0.291)	0.212 (0.389)
Week 105	Number Analyzed	11 participants	12 participants
		0.216 (0.291)	0.174 (0.399)
Week 107	Number Analyzed	11 participants	13 participants
		0.182 (0.273)	0.245 (0.459)
Week 109	Number Analyzed	10 participants	11 participants
		0.207 (0.311)	0.254 (0.507)
Week 111	Number Analyzed	11 participants	12 participants
		0.282 (0.556)	0.263 (0.459)
Week 113	Number Analyzed	11 participants	12 participants
		0.248 (0.366)	0.335 (0.614)
Week 115	Number Analyzed	10 participants	11 participants
		0.324 (0.413)	0.165 (0.432)
Week 117	Number Analyzed	9 participants	10 participants
		0.450 (0.492)	0.181 (0.489)
Week 119	Number Analyzed	9 participants	10 participants
		0.348 (0.400)	0.187 (0.404)
Week 121	Number Analyzed	9 participants	8 participants
		0.459 (0.414)	0.174 (0.479)
Week 123	Number Analyzed	9 participants	9 participants
		0.350 (0.375)	0.192 (0.512)
Week 125	Number Analyzed	8 participants	7 participants
		0.303 (0.425)	0.114 (0.298)
Week 127	Number Analyzed	7 participants	8 participants
		0.309 (0.401)	0.220 (0.420)
Week 129	Number Analyzed	7 participants	7 participants
		0.393 (0.506)	0.191 (0.506)
Week 131	Number Analyzed	6 participants	5 participants
		0.480 (0.529)	0.222 (0.430)
Week 133	Number Analyzed	5 participants	4 participants
		0.342 (0.469)	0.125 (0.155)
Week 135	Number Analyzed	5 participants	5 participants
		0.454 (0.643)	0.280 (0.425)
Week 137	Number Analyzed	4 participants	3 participants
		0.545 (0.631)	0.070 (0.121)
Week 139	Number Analyzed	5 participants	3 participants
		0.494 (0.676)	0.293 (0.508)
Week 141	Number Analyzed	3 participants	2 participants
		0.667 (0.583)	0.025 (0.035)
Week 143	Number Analyzed	4 participants	3 participants
		0.513 (0.604)	0.270 (0.292)
Week 145	Number Analyzed	2 participants	3 participants
		0.580 (0.820)	0.130 (0.141)
Week 147	Number Analyzed	3 participants	2 participants
		0.400 (0.592)	0.195 (0.276)
Week 149	Number Analyzed	1 participants	2 participants
		0.000	0.000 (0.000)
Week 151	Number Analyzed	2 participants	1 participants
		0.000 (0.000)	0.000
Week 153	Number Analyzed	1 participants	1 participants
		0.000	0.000
Week 155	Number Analyzed	1 participants	1 participants
		0.000	0.000
Week 157	Number Analyzed	1 participants	1 participants
		0.000	0.000
Week 159	Number Analyzed	1 participants	1 participants
		0.000	0.000
Week 161	Number Analyzed	1 participants	1 participants
		0.180	0.000
Week 163	Number Analyzed	1 participants	1 participants
		0.000	0.000
Week 165	Number Analyzed	1 participants	0 participants
		0.000
Week 167	Number Analyzed	1 participants	0 participants
		0.000
Week 169	Number Analyzed	1 participants	0 participants
		0.000
Week 171	Number Analyzed	1 participants	0 participants
		0.000
Week 173	Number Analyzed	1 participants	0 participants
		0.000
Week 175	Number Analyzed	1 participants	0 participants
		0.000
ET/SFU Visit	Number Analyzed	19 participants	18 participants
		0.055 (0.200)	0.181 (0.426)

18. Secondary Outcome

Title	Part B: Number of Healthcare Visits by Type
Description	In this outcome measure, number of healthcare visits which included non-study healthcare resource utilization visit (consisted mainly of extra visits to the office of the study doctor, visit to a generalist doctor or visit to a specialist doctor), hospitalization visit and visit to hospital emergency is reported.
Time Frame	From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)

Outcome Measure Data

Analysis Population Description

Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).

Arm/Group Title	BIVV009/BIVV009	Placebo/BIVV009
Arm/Group Description:	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.	Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed	19	20
Measure Type: Number; Unit of Measure: visits
Non-study healthcare resource utilization visits	13	12
Hospitalization	3	1
Visit to a hospital emergency room	1	3

Adverse Events

Time Frame	Part A (both 6.5 g and 7.5 g cohorts): first dose (Day 0) up to Week 25; Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172)
Adverse Event Reporting Description	Reported AEs and SAEs including fatal AEs were TEAEs that developed/worsened or became serious during on-treatment period. Analysis was performed on SAS.
Arm/Group Title	Part A: BIVV009 6.5 g		Part A: BIVV009 7.5 g		Part A: Placebo		Part B: BIVV009 6.5 g		Part B: BIVV009 7.5 g
Arm/Group Description	Participants with primary CAD and body weight <75 kg and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.		Participants with primary CAD and body weight >=75 kg and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 7.5 g on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.		Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.		Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 149 weeks. Participants who received placebo in Part A received BIVV009 6.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 6.5 g in Part A received placebo on Week 26, BIVV009 6.5 g on Week 27 and every 2 weeks thereafter for up to an additional 149 weeks.		Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 137 weeks. Participants who received placebo in Part A received BIVV009 7.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 7.5 g in Part A received placebo on Week 26, BIVV009 7.5 g on Week 27 and every 2 weeks thereafter for up to an additional 137 weeks.
All-Cause Mortality
	Part A: BIVV009 6.5 g		Part A: BIVV009 7.5 g		Part A: Placebo		Part B: BIVV009 6.5 g		Part B: BIVV009 7.5 g
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/17 (0.00%)		0/5 (0.00%)		0/20 (0.00%)		1/32 (3.13%)		0/7 (0.00%)
Serious Adverse Events
	Part A: BIVV009 6.5 g		Part A: BIVV009 7.5 g		Part A: Placebo		Part B: BIVV009 6.5 g		Part B: BIVV009 7.5 g
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/17 (11.76%)		1/5 (20.00%)		0/20 (0.00%)		6/32 (18.75%)		1/7 (14.29%)
Blood and lymphatic system disorders
Anaemia † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Congenital, familial and genetic disorders
Polycystic Liver Disease † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Hepatobiliary disorders
Cholelithiasis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Infections and infestations
Febrile Infection † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Urinary Tract Infection † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Injury, poisoning and procedural complications
Hip Fracture † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Muscle Strain † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Investigations
Blood Immunoglobulin M Increased † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Osteoarthritis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	1/7 (14.29%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Lung † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Nervous system disorders
Cerebral Venous Sinus Thrombosis † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Vascular disorders
Hypertension † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Raynaud's Phenomenon † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
1 Term from vocabulary, MedDRA 24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part A: BIVV009 6.5 g		Part A: BIVV009 7.5 g		Part A: Placebo		Part B: BIVV009 6.5 g		Part B: BIVV009 7.5 g
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/17 (94.12%)		5/5 (100.00%)		3/20 (15.00%)		28/32 (87.50%)		7/7 (100.00%)
Blood and lymphatic system disorders
Anaemia † 1	0/17 (0.00%)	0	2/5 (40.00%)	2	0/20 (0.00%)	0	9/32 (28.13%)	11	2/7 (28.57%)	3
Blood Loss Anaemia † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Haemolysis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	2	0/7 (0.00%)	0
Iron Deficiency Anaemia † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	3/32 (9.38%)	4	1/7 (14.29%)	1
Leukocytosis † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Cardiac disorders
Palpitations † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	2/7 (28.57%)	2
Tachycardia † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	1/7 (14.29%)	1
Ear and labyrinth disorders
Tinnitus † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	2	0/7 (0.00%)	0
Eye disorders
Visual Acuity Reduced † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Gastrointestinal disorders
Abdominal Pain † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	3/32 (9.38%)	3	0/7 (0.00%)	0
Abdominal Pain Upper † 1	1/17 (5.88%)	1	1/5 (20.00%)	1	0/20 (0.00%)	0	2/32 (6.25%)	2	0/7 (0.00%)	0
Angular Cheilitis † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Colitis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Constipation † 1	2/17 (11.76%)	4	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	3	0/7 (0.00%)	0
Dental Caries † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Diarrhoea † 1	1/17 (5.88%)	1	1/5 (20.00%)	4	0/20 (0.00%)	0	6/32 (18.75%)	13	1/7 (14.29%)	1
Dyspepsia † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	3/32 (9.38%)	4	0/7 (0.00%)	0
Faeces Discoloured † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Gastrooesophageal Reflux Disease † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Glossodynia † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Nausea † 1	1/17 (5.88%)	2	0/5 (0.00%)	0	0/20 (0.00%)	0	3/32 (9.38%)	3	2/7 (28.57%)	2
Odynophagia † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Paraesthesia Oral † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Tongue Ulceration † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Toothache † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Vomiting † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	2	0/7 (0.00%)	0
General disorders
Asthenia † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	4/32 (12.50%)	6	2/7 (28.57%)	2
Catheter Site Dryness † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Chest Discomfort † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Chest Pain † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Chills † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Fatigue † 1	1/17 (5.88%)	1	1/5 (20.00%)	2	0/20 (0.00%)	0	7/32 (21.88%)	7	5/7 (71.43%)	10
General Physical Health Deterioration † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	1/7 (14.29%)	1
Influenza Like Illness † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Injection Site Erythema † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	3	0/7 (0.00%)	0
Injection Site Pruritus † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Malaise † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Non-Cardiac Chest Pain † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	1/7 (14.29%)	1
Oedema Peripheral † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	2	1/7 (14.29%)	1
Pyrexia † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	5/32 (15.63%)	6	1/7 (14.29%)	1
Vaccination Site Erythema † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Vaccination Site Pain † 1	1/17 (5.88%)	1	1/5 (20.00%)	1	0/20 (0.00%)	0	2/32 (6.25%)	2	1/7 (14.29%)	1
Vaccination Site Rash † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Hepatobiliary disorders
Biliary Colic † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Cholelithiasis † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Immune system disorders
Seasonal Allergy † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	1/32 (3.13%)	1	1/7 (14.29%)	1
Infections and infestations
Anal Abscess † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Cystitis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	2	2/7 (28.57%)	2
Diverticulitis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	2/32 (6.25%)	2	0/7 (0.00%)	0
Gastroenteritis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	3/32 (9.38%)	3	1/7 (14.29%)	1
Herpes Zoster † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Influenza † 1	2/17 (11.76%)	2	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Mastoiditis † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Nasopharyngitis † 1	0/17 (0.00%)	0	2/5 (40.00%)	2	0/20 (0.00%)	0	5/32 (15.63%)	9	2/7 (28.57%)	3
Oral Candidiasis † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	1/7 (14.29%)	1
Oral Herpes † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Pneumonia † 1	0/17 (0.00%)	0	1/5 (20.00%)	1	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Respiratory Tract Infection † 1	0/17 (0.00%)	0	0/5 (0.00%)	0	1/20 (5.00%)	1	1/32 (3.13%)	1	1/7 (14.29%)	1
Rhinitis † 1	3/17 (17.65%)	3	1/5 (20.00%)	1	0/20 (0.00%)	0	2/32 (6.25%)	4	1/7 (14.29%)	1
Sinusitis † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	1/32 (3.13%)	1	0/7 (0.00%)	0
Skin Candida † 1	1/17 (5.88%)	1	0/5 (0.00%)	0	0/20 (0.00%)	0	0/32 (0.00%)	0	0/7 (0.00%)	0
Staphylococcal Skin Infection † 1	1/17 (5.88%)	2	0/5 (0.00%)	0	0/20 (0.00%)	0