Trial Outcomes & Findings for Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD (NCT NCT00752557)

NCT ID: NCT00752557

Last Updated: 2020-03-20

Results Overview

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline, 12 months post dose
• Results posted on: 2020-03-20

Participant Flow

The study was conducted at 10 centers in the United States of America, Belgium, and Poland.

Treatment assignments were stratified by previous osteoporosis (OP) therapy regardless of rhBMP-2/CPM treatment assignment; bisphosphonate, calcium, vitamin D were provided to all participants as background concomitant OP therapy.

Participant milestones

Measure	Standard of Care Control Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPM 2.0mg/mL Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in both injected treatment groups additionally received SOC treatment for OP.
Overall Study STARTED	17	16	17
Overall Study COMPLETED	12	11	11
Overall Study NOT COMPLETED	5	5	6

Reasons for withdrawal

Measure	Standard of Care Control Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPM 2.0mg/mL Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in both injected treatment groups additionally received SOC treatment for OP.
Overall Study Withdrawal by Subject	4	3	3
Overall Study Unspecified resaons	0	2	2
Overall Study Lost to Follow-up	1	0	1

Baseline Characteristics

Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

Baseline characteristics by cohort

Measure	Standard of Care Control n=17 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=15 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	Total n=46 Participants Total of all reporting groups
Age, Continuous	73.35 Years STANDARD_DEVIATION 5.454 • n=5 Participants	75.93 Years STANDARD_DEVIATION 5.271 • n=7 Participants	73.21 Years STANDARD_DEVIATION 5.041 • n=5 Participants	74.15 Years STANDARD_DEVIATION 5.304 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	46 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months post dose

Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.

Outcome measures

Measure	Standard of Care Control n=14 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=12 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) Total hip	-0.0026 gram per centimeter squared (g/cm^2) Standard Deviation 0.018	0.1299 gram per centimeter squared (g/cm^2) Standard Deviation 0.045	0.1196 gram per centimeter squared (g/cm^2) Standard Deviation 0.063
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) Intertrochanter	-0.0029 gram per centimeter squared (g/cm^2) Standard Deviation 0.020	0.1063 gram per centimeter squared (g/cm^2) Standard Deviation 0.066	0.1192 gram per centimeter squared (g/cm^2) Standard Deviation 0.063
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) Trochanter	-0.0091 gram per centimeter squared (g/cm^2) Standard Deviation 0.023	0.1197 gram per centimeter squared (g/cm^2) Standard Deviation 0.066	0.0869 gram per centimeter squared (g/cm^2) Standard Deviation 0.073
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) Femoral neck	0.0058 gram per centimeter squared (g/cm^2) Standard Deviation 0.021	0.2408 gram per centimeter squared (g/cm^2) Standard Deviation 0.111	0.2120 gram per centimeter squared (g/cm^2) Standard Deviation 0.117

PRIMARY outcome

Timeframe: At Month 12

Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).

Outcome measures

Measure	Standard of Care Control n=13 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=11 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip Cortical + Sub-Cortical	136.8 milligram per centimeter cubed (mg/cm^3) Standard Deviation 16.91	165.6 milligram per centimeter cubed (mg/cm^3) Standard Deviation 18.37	151.6 milligram per centimeter cubed (mg/cm^3) Standard Deviation 26.07
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip Peeled Trabecular	45.1 milligram per centimeter cubed (mg/cm^3) Standard Deviation 16.02	77.8 milligram per centimeter cubed (mg/cm^3) Standard Deviation 23.07	88.4 milligram per centimeter cubed (mg/cm^3) Standard Deviation 37.63
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip Integral	181.9 milligram per centimeter cubed (mg/cm^3) Standard Deviation 20.60	243.4 milligram per centimeter cubed (mg/cm^3) Standard Deviation 31.04	240.0 milligram per centimeter cubed (mg/cm^3) Standard Deviation 45.31

PRIMARY outcome

Timeframe: At Month 12

Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.

Outcome measures

Measure	Standard of Care Control n=13 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=11 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck Cortical +Sub Cortical	144.3 mg/cm^3 Standard Deviation 16.81	166.3 mg/cm^3 Standard Deviation 31.06	164.4 mg/cm^3 Standard Deviation 29.37
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck Peeled Trabecular	61.1 mg/cm^3 Standard Deviation 14.39	165.0 mg/cm^3 Standard Deviation 59.13	159.3 mg/cm^3 Standard Deviation 38.97
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck Integral	205.4 mg/cm^3 Standard Deviation 23.02	331.3 mg/cm^3 Standard Deviation 73.99	323.7 mg/cm^3 Standard Deviation 58.96

SECONDARY outcome

Timeframe: 24 months

Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.

Outcome measures

Measure	Standard of Care Control n=5 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=7 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=6 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) Cortical Bone	2.5782 mg/cm^3 Standard Deviation 0.16805	2.4259 mg/cm^3 Standard Deviation 0.24267	2.5128 mg/cm^3 Standard Deviation 0.17484
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) Trabecular Bone	0 mg/cm^3 Standard Deviation 0	4.7073 mg/cm^3 Standard Deviation 2.40500	4.2205 mg/cm^3 Standard Deviation 1.63904

SECONDARY outcome

Timeframe: Participants were monitored after treatment administration (dosing period)

Population: Only those participants who were injected with rhBMP-2/CPM were included in the injected population. Any participant who received SOC alone was excluded from this population.

Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.

Outcome measures

Measure	Standard of Care Control n=15 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=14 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Number Participant Responses to Injectability Questionnaire Injected Population Ease of Preparing-satisfactory	15 Participants	14 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Ease of Preparing-unsatisfactory	0 Participants	0 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Ease of Injecting-satisfactory	15 Participants	11 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Ease of Injecting-unsatisfactory	0 Participants	3 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Ability to inject entire volume- satisfactory	13 Participants	12 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Ability to inject entire volume- unsatisfactory	2 Participants	2 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Localization within Proximal Femur-satisfactory	15 Participants	11 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Localization within Proximal Femur-unsatisfactory	0 Participants	2 Participants	—
Number Participant Responses to Injectability Questionnaire Injected Population Missing	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline up to 12 months

Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).

Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.

Outcome measures

Measure	Standard of Care Control n=17 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=15 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 36 months

Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.

Outcome measures

Measure	Standard of Care Control n=10 Participants Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=12 Participants Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=12 Participants Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip	0.73 Percent change Standard Deviation 0.057	0.71 Percent change Standard Deviation 0.045	0.71 Percent change Standard Deviation 0.110

Adverse Events

Standard of Care Control

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

rhBMP-2/CPM 1.0 mg/mL

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

rhBMP-2/CPm 2.0 mg/mL

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard of Care Control n=17 participants at risk Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=15 participants at risk Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 participants at risk Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Cardiac disorders Angina Pectoris	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Cardiac disorders Myocardial Infarction	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Bronchopneumonia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Femur fracture	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Cystitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Oesophagitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Fall	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Nuclear magnetic resonance imaging abnormal	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Bone infarction	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Intracranial aneurysm	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Syncope	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Transient ischaemic attack	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Renal and urinary disorders Haematuria	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).

Other adverse events

Measure	Standard of Care Control n=17 participants at risk Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician.	rhBMP-2/CPM 1.0 mg/mL n=15 participants at risk Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.	rhBMP-2/CPm 2.0 mg/mL n=14 participants at risk Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP.
Blood and lymphatic system disorders Anaemia	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Blood and lymphatic system disorders Bone marrow oedema	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Blood and lymphatic system disorders Lymph node calcification	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Cardiac disorders Atrioventricular block first degree	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Cardiac disorders Chronotropic incompetence	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Cardiac disorders Supraventricular extrasystoles	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Ear and labyrinth disorders Ear pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Ear and labyrinth disorders Vertigo	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Endocrine disorders Hypothyroidism	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Blepharitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Choroidal haemorrhage	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Dark circles under eyes	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Eye pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Eyelid ptosis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Cataract	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Macular generation	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Ocular hyperaemia	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders retinal haemorrhage	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Eye disorders Visual acuity reduced	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Abdominal distension	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Cheilitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Constipation	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	20.0% 3/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Diarrhoea	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Dry mouth	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Dysphagia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Gastric ulcer	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Gastritis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Haemorrhoids	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Hiatus hernia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Nausea	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	40.0% 6/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	35.7% 5/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Oesophagitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Oral discomfort	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Pancreatic cyst	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Gastrointestinal disorders Vomiting	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	20.0% 3/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	21.4% 3/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Breakthrough pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Chills	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Facial pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Fatigue	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Gait deviation	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Gait disturbance	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Injection site bruising	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Injection site discharge	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Injection site erythema	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Injection site mass	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Injection site pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	35.7% 5/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Injection site swelling	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Malaise	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Non-cardiac chest pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Oedema	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Oedema peripheral	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Pain	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Peripheral swelling	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Pyrexia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
General disorders Soft tissue inflammation	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Immune system disorders Seasonal allergy	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Arthritis infective	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Bronchitis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Coccidioidomycosis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Cystitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Diarrhoea infectious	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Gastroenteritis viral	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Influenza	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Labyrinthitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Lung infection	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Nasopharyngitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Onychomycosis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Oral herpes	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Osteomyelitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Pharyngitis streptococcal	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Pneumonia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Rhinitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Sinusitis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Tooth infection	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Upper respiratory tract infection	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Urinary tract infection	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Infections and infestations Vulvovaginal mycotic infection	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Contusion	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Epicondylitis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Fall	23.5% 4/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	33.3% 5/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	21.4% 3/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Hand fracture	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Head injury	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Injection related reaction	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Joint injury	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Laceration	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Ligament sprain	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Limb injury	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Lower limb fracture	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Patella fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	35.7% 5/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Road traffic accident	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Superficial injury of eye	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Wound	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Alanine aminotransferase increased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Aspartate aminotransferase increased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Chest X-ray abnormal	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Scan bone marrow abnormal	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Urine output increased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Investigations Weight decreased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Metabolism and nutrition disorders Hypokalaemia	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Metabolism and nutrition disorders Iodine deficiency	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Arthralgia	29.4% 5/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	80.0% 12/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	64.3% 9/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Arthritis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	26.7% 4/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	21.4% 3/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Bursitis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Joint swelling	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	20.0% 3/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	28.6% 4/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Muscle swelling	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	20.0% 3/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Osteitis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Osteoarthritis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Pain in extremity	17.6% 3/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	28.6% 4/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Plantar fasciitis	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Musculoskeletal and connective tissue disorders Weight bearing difficulty	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic naevus	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Balance disorder	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Dizziness	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Dizziness postural	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Headache	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Hypoaesthesia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Lethargy	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Loss of consciousness	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Meralgia paraesthetica	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Neuralgia	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Peroneal nerve palsy	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Sciatica	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders Sinus headache	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Nervous system disorders VIIth nerve paralysis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Psychiatric disorders Depression	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Psychiatric disorders Anxiety	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Psychiatric disorders Insomnia	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	14.3% 2/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Renal and urinary disorders Dysuria	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Renal and urinary disorders Haematuria	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Renal and urinary disorders Incontinence	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Renal and urinary disorders Renal failure	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Choking sensation	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Cough	17.6% 3/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	21.4% 3/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.8% 2/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Acne	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Dandruff	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Ingrowing nail	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Rash	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Skin lesion	5.9% 1/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Vascular disorders Aortic calcification	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Vascular disorders Hypertension	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	7.1% 1/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Vascular disorders Hypotension	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	13.3% 2/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
Vascular disorders Vascular calcification	0.00% 0/17 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	6.7% 1/15 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).	0.00% 0/14 • Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. The as-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.
• Publication restrictions are in place

Restriction type: OTHER