Trial Outcomes & Findings for A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee (NCT NCT01919164)

NCT ID: NCT01919164

Last Updated: 2020-07-13

Results Overview

The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 549 participants
• Primary outcome timeframe: Baseline, Year 2 (Week 104)
• Results posted on: 2020-07-13

Participant Flow

A total of 549 participants were randomized in this study.

Participant milestones

Measure	Placebo Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Overall Study STARTED	108	110	111	110	110
Overall Study Safety Analysis Set	107	109	111	111	109
Overall Study COMPLETED	65	80	74	82	77
Overall Study NOT COMPLETED	43	30	37	28	33

Reasons for withdrawal

Measure	Placebo Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Overall Study Adverse Event	6	4	9	3	2
Overall Study Lost to Follow-up	2	2	2	0	4
Overall Study Death	1	0	0	0	0
Overall Study Protocol Violation	6	0	3	2	2
Overall Study Disease progression	2	2	1	2	1
Overall Study Withdrew consent	13	13	14	14	9
Overall Study Other Un-specified	13	9	8	7	15

Baseline Characteristics

A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee

Baseline characteristics by cohort

Measure	Placebo n=108 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=110 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=111 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo- 2 Cycles n=110 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=110 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Total n=549 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	46 Participants n=7 Participants	52 Participants n=5 Participants	52 Participants n=4 Participants	46 Participants n=21 Participants	250 Participants n=10 Participants
Age, Categorical >=65 years	54 Participants n=5 Participants	64 Participants n=7 Participants	59 Participants n=5 Participants	58 Participants n=4 Participants	64 Participants n=21 Participants	299 Participants n=10 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	73 Participants n=7 Participants	80 Participants n=5 Participants	77 Participants n=4 Participants	73 Participants n=21 Participants	379 Participants n=10 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	37 Participants n=7 Participants	31 Participants n=5 Participants	33 Participants n=4 Participants	37 Participants n=21 Participants	170 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants n=5 Participants	109 Participants n=7 Participants	111 Participants n=5 Participants	110 Participants n=4 Participants	110 Participants n=21 Participants	547 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	23 Participants n=4 Participants	21 Participants n=21 Participants	110 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	88 Participants n=7 Participants	88 Participants n=5 Participants	87 Participants n=4 Participants	89 Participants n=21 Participants	439 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Year 2 (Week 104)

Population: Modified intent to treat (ITT) analysis set included all randomized participants that is, only planned treatment regimen was used and who had a baseline, at least 1 post-treatment qMRI assessment available in double-blind placebo-controlled part. Here "Number of Participants analyzed" = participants evaluable for this outcome measure.

The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI).

Outcome measures

Measure	Placebo n=83 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=92 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=83 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=90 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=86 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2	-0.02 millimeters Standard Deviation 0.07	-0.01 millimeters Standard Deviation 0.07	0.00 millimeters Standard Deviation 0.07	0.02 millimeters Standard Deviation 0.08	0.03 millimeters Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline, Week 52, Week 78 and Week 104

Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat "as randomized" principle. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" included those who were evaluable at specified timepoints.

WOMAC pain subscale consists of 5 questions (Likert Scale) relating to pain. Sum of items of pain subscale ranges from 0-11. Higher scores=worse pain. Stiffness subscale consists of 2 questions relating articular function. Sum of items of stiffness subscale ranges from 0-8. Higher scores=worse function. Physical function subscale consists of 17 question relating to physical activities. Sum of items of physical function subscale ranges from 0-68. Higher scores= worse functional limitations. Each sub-scale is directly transformed into a 0-100 scale, where higher score indicates worse condition. WOMAC total score(24questions) is sum of total subscales which was directly transformed into score range from 0-100. Higher scores=worse condition. Negative value in change is indicative of improvement.

Outcome measures

Measure	Placebo n=94 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=98 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=89 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=98 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=100 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Total: Change at Week 78	-18.41 score on a scale Standard Deviation 20.43	-19.34 score on a scale Standard Deviation 19.15	-16.36 score on a scale Standard Deviation 20.35	-18.88 score on a scale Standard Deviation 18.15	-20.29 score on a scale Standard Deviation 18.49
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Pain: Change at Week 52	-18.51 score on a scale Standard Deviation 19.49	-21.55 score on a scale Standard Deviation 18.36	-15.40 score on a scale Standard Deviation 18.31	-21.12 score on a scale Standard Deviation 19.73	-23.34 score on a scale Standard Deviation 17.92
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Pain: Change at Week 78	-21.04 score on a scale Standard Deviation 20.81	-23.00 score on a scale Standard Deviation 20.42	-18.19 score on a scale Standard Deviation 21.15	-23.21 score on a scale Standard Deviation 19.42	-23.23 score on a scale Standard Deviation 18.41
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Pain: Change at Week 104	-25.37 score on a scale Standard Deviation 20.60	-23.22 score on a scale Standard Deviation 21.42	-21.42 score on a scale Standard Deviation 21.37	-23.15 score on a scale Standard Deviation 18.18	-26.06 score on a scale Standard Deviation 18.39
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Stiffness: Change at Week 52	-18.88 score on a scale Standard Deviation 24.72	-18.52 score on a scale Standard Deviation 22.89	-11.09 score on a scale Standard Deviation 21.14	-16.68 score on a scale Standard Deviation 20.93	-17.35 score on a scale Standard Deviation 22.16
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Stiffness: Change at Week 78	-20.44 score on a scale Standard Deviation 26.76	-19.47 score on a scale Standard Deviation 25.87	-14.94 score on a scale Standard Deviation 23.66	-19.63 score on a scale Standard Deviation 20.38	-21.44 score on a scale Standard Deviation 23.99
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Stiffness: Change at Week 104	-23.20 score on a scale Standard Deviation 25.84	-20.56 score on a scale Standard Deviation 23.93	-17.75 score on a scale Standard Deviation 22.74	-17.76 score on a scale Standard Deviation 20.75	-22.79 score on a scale Standard Deviation 24.60
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Function: Change at Week 52	-15.51 score on a scale Standard Deviation 19.14	-16.84 score on a scale Standard Deviation 17.64	-12.01 score on a scale Standard Deviation 18.04	-14.80 score on a scale Standard Deviation 19.07	-16.91 score on a scale Standard Deviation 19.69
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Function: Change at Week 78	-17.38 score on a scale Standard Deviation 21.01	-18.23 score on a scale Standard Deviation 19.41	-16.00 score on a scale Standard Deviation 20.82	-17.51 score on a scale Standard Deviation 18.96	-19.29 score on a scale Standard Deviation 19.56
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Function: Change at Week 104	-20.89 score on a scale Standard Deviation 20.10	-20.00 score on a scale Standard Deviation 20.99	-19.06 score on a scale Standard Deviation 21.52	-17.03 score on a scale Standard Deviation 20.16	-20.82 score on a scale Standard Deviation 20.39
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Total: Change at Week 52	-16.42 score on a scale Standard Deviation 18.61	-17.97 score on a scale Standard Deviation 16.95	-12.64 score on a scale Standard Deviation 17.42	-16.29 score on a scale Standard Deviation 18.35	-18.29 score on a scale Standard Deviation 18.25
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 Total: Change at Week 104	-22.02 score on a scale Standard Deviation 19.70	-20.73 score on a scale Standard Deviation 20.22	-19.44 score on a scale Standard Deviation 20.88	-18.37 score on a scale Standard Deviation 18.69	-22.08 score on a scale Standard Deviation 19.11

SECONDARY outcome

Timeframe: Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104

Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat "as randomized" principle. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" included those who were evaluable at specified timepoints.

The 20-meter walk test is an objective test of physical function which consists of measuring the time needed for the participant to walk 20 meters at a normal pace. A stopwatch was used for time measurement.

Outcome measures

Measure	Placebo n=105 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=108 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=109 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=107 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=108 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 12	-1.2 seconds Standard Deviation 2.9	-0.4 seconds Standard Deviation 4.0	-0.5 seconds Standard Deviation 2.6	-0.8 seconds Standard Deviation 2.2	-1.1 seconds Standard Deviation 3.3
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 26	-1.3 seconds Standard Deviation 3.7	-0.4 seconds Standard Deviation 3.9	-0.3 seconds Standard Deviation 2.6	-1.1 seconds Standard Deviation 2.8	-1.3 seconds Standard Deviation 3.0
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 38	-1.1 seconds Standard Deviation 3.6	-0.5 seconds Standard Deviation 3.4	-0.7 seconds Standard Deviation 2.5	-1.0 seconds Standard Deviation 2.9	-1.4 seconds Standard Deviation 3.2
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 52	-1.7 seconds Standard Deviation 4.2	-1.1 seconds Standard Deviation 3.6	-0.7 seconds Standard Deviation 2.5	-0.4 seconds Standard Deviation 7.9	-1.3 seconds Standard Deviation 2.8
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 64	-1.8 seconds Standard Deviation 3.6	-1.5 seconds Standard Deviation 4.1	-0.9 seconds Standard Deviation 2.5	-1.3 seconds Standard Deviation 2.6	-1.6 seconds Standard Deviation 3.4
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 78	-1.6 seconds Standard Deviation 3.7	-1.0 seconds Standard Deviation 4.0	-0.8 seconds Standard Deviation 2.8	-1.6 seconds Standard Deviation 3.0	-1.3 seconds Standard Deviation 3.2
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 90	-2.1 seconds Standard Deviation 3.9	-1.0 seconds Standard Deviation 3.2	-1.1 seconds Standard Deviation 2.7	-1.8 seconds Standard Deviation 3.1	-1.7 seconds Standard Deviation 3.5
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 104	-1.6 seconds Standard Deviation 4.0	-1.2 seconds Standard Deviation 4.1	-0.8 seconds Standard Deviation 3.4	-1.4 seconds Standard Deviation 2.9	-1.3 seconds Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104

Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat "as randomized" principle. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" included those who were evaluable at specified timepoints.

The Patient Global Assessment is based on participant's answer to the question "Considering all the ways your osteoarthritis of the knee has affected you during the last 48 Hours, select the number that best describes the impact of your knee osteoarthritis on your daily life", and can take on values between 0-10 (0=None, 10=Extreme), for summaries the values are rescaled to 0-100 by multiplication with 10. Higher scores indicated worsening of condition. A negative value in change in Patient's Global Assessment is indicative of an improvement.

Outcome measures

Measure	Placebo n=104 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=108 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=109 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=106 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=107 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 38	-18.9 score on a scale Standard Deviation 26.2	-17.2 score on a scale Standard Deviation 22.5	-19.2 score on a scale Standard Deviation 24.9	-20.5 score on a scale Standard Deviation 24.3	-18.4 score on a scale Standard Deviation 25.1
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 12	-16.6 score on a scale Standard Deviation 23.5	-13.9 score on a scale Standard Deviation 20.6	-17.0 score on a scale Standard Deviation 25.0	-15.0 score on a scale Standard Deviation 23.2	-16.7 score on a scale Standard Deviation 22.1
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 26	-16.3 score on a scale Standard Deviation 22.3	-15.1 score on a scale Standard Deviation 22.7	-17.7 score on a scale Standard Deviation 25.3	-18.7 score on a scale Standard Deviation 22.4	-19.1 score on a scale Standard Deviation 24.1
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 52	-19.6 score on a scale Standard Deviation 25.8	-20.9 score on a scale Standard Deviation 21.2	-18.0 score on a scale Standard Deviation 23.9	-19.5 score on a scale Standard Deviation 25.2	-21.6 score on a scale Standard Deviation 24.0
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 64	-22.7 score on a scale Standard Deviation 24.6	-21.7 score on a scale Standard Deviation 21.9	-22.3 score on a scale Standard Deviation 23.0	-21.6 score on a scale Standard Deviation 25.8	-21.3 score on a scale Standard Deviation 24.6
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 78	-22.7 score on a scale Standard Deviation 26.5	-21.5 score on a scale Standard Deviation 24.1	-23.1 score on a scale Standard Deviation 25.7	-22.0 score on a scale Standard Deviation 25.4	-24.2 score on a scale Standard Deviation 24.1
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 90	-25.8 score on a scale Standard Deviation 25.6	-22.3 score on a scale Standard Deviation 24.5	-21.7 score on a scale Standard Deviation 24.8	-21.1 score on a scale Standard Deviation 26.3	-26.2 score on a scale Standard Deviation 24.9
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 Change at Week 104	-27.5 score on a scale Standard Deviation 25.0	-23.0 score on a scale Standard Deviation 22.3	-23.8 score on a scale Standard Deviation 24.9	-22.1 score on a scale Standard Deviation 25.6	-25.8 score on a scale Standard Deviation 22.8

SECONDARY outcome

Timeframe: Baseline, Week 52 and 104

Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat "as randomized" principle. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" included those who were evaluable at specified timepoints.

Change in joint space narrowing was visualized with the "fixed flexion" knee radiograph. Determination of joint space narrowing by X-ray is considered to be a semi-quantitative method for assessment of progression of knee Osteoarthritis (OA). X-rays of both the target knee and the contralateral knee were performed. X-rays were read centrally. X-ray images were used to measure mJSW in the medial femorotibial and lateral femorotibial compartments and to determine the participant's baseline Kellgren-Lawrence grades (KLG).

Outcome measures

Measure	Placebo n=95 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=101 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=95 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=100 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=101 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 Lateral: Change at Week 52	0.07 millimeter Standard Deviation 0.46	-0.03 millimeter Standard Deviation 0.62	0.16 millimeter Standard Deviation 0.54	0.10 millimeter Standard Deviation 0.37	0.14 millimeter Standard Deviation 0.43
Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 Medial: Change at Week 52	-0.10 millimeter Standard Deviation 0.48	-0.05 millimeter Standard Deviation 0.53	-0.04 millimeter Standard Deviation 0.43	0.02 millimeter Standard Deviation 0.55	-0.04 millimeter Standard Deviation 0.57
Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 Medial: Change at Week 104	-0.11 millimeter Standard Deviation 0.59	-0.09 millimeter Standard Deviation 0.73	0.03 millimeter Standard Deviation 0.52	-0.05 millimeter Standard Deviation 0.66	-0.07 millimeter Standard Deviation 0.86
Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 Lateral: Change at Week 104	-0.07 millimeter Standard Deviation 0.49	-0.03 millimeter Standard Deviation 0.64	0.01 millimeter Standard Deviation 0.65	0.19 millimeter Standard Deviation 0.49	0.19 millimeter Standard Deviation 0.49

SECONDARY outcome

Timeframe: Medial and Lateral: Baseline, Week 26, 52, 78 and 104; Total: Baseline, Week 26, 52 and 78

Population: Modified ITT analysis set was used. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" included those who were evaluable at specified timepoints.

The change in cartilage thickness was calculated based on quantitative magnetic resonance imaging (qMRI).

Outcome measures

Measure	Placebo n=94 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=97 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=97 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=96 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=99 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Medial: Change at Week 78	-0.01 millimeter Standard Deviation 0.07	-0.01 millimeter Standard Deviation 0.07	0.01 millimeter Standard Deviation 0.06	0.01 millimeter Standard Deviation 0.10	0.03 millimeter Standard Deviation 0.08
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Medial: Change at Week 104	-0.03 millimeter Standard Deviation 0.12	-0.02 millimeter Standard Deviation 0.10	-0.01 millimeter Standard Deviation 0.08	0.00 millimeter Standard Deviation 0.11	0.02 millimeter Standard Deviation 0.08
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Medial: Change at Week 26	0.00 millimeter Standard Deviation 0.06	0.00 millimeter Standard Deviation 0.06	-0.01 millimeter Standard Deviation 0.06	0.01 millimeter Standard Deviation 0.05	0.01 millimeter Standard Deviation 0.06
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Medial: Change at Week 52	-0.01 millimeter Standard Deviation 0.06	-0.01 millimeter Standard Deviation 0.07	-0.01 millimeter Standard Deviation 0.06	0.00 millimeter Standard Deviation 0.07	0.01 millimeter Standard Deviation 0.06
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Lateral: Change at Week 26	-0.01 millimeter Standard Deviation 0.05	0.00 millimeter Standard Deviation 0.05	0.00 millimeter Standard Deviation 0.06	0.02 millimeter Standard Deviation 0.05	0.02 millimeter Standard Deviation 0.05
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Lateral: Change at Week 52	-0.01 millimeter Standard Deviation 0.05	-0.01 millimeter Standard Deviation 0.07	0.00 millimeter Standard Deviation 0.05	0.02 millimeter Standard Deviation 0.06	0.02 millimeter Standard Deviation 0.05
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Lateral: Change at Week 78	0.00 millimeter Standard Deviation 0.05	0.01 millimeter Standard Deviation 0.06	0.01 millimeter Standard Deviation 0.08	0.03 millimeter Standard Deviation 0.07	0.03 millimeter Standard Deviation 0.06
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Lateral: Change at Week 104	-0.01 millimeter Standard Deviation 0.05	-0.01 millimeter Standard Deviation 0.07	0.00 millimeter Standard Deviation 0.09	0.04 millimeter Standard Deviation 0.07	0.04 millimeter Standard Deviation 0.06
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Total: Change at Week 26	-0.01 millimeter Standard Deviation 0.05	0.00 millimeter Standard Deviation 0.04	0.00 millimeter Standard Deviation 0.05	0.01 millimeter Standard Deviation 0.04	0.01 millimeter Standard Deviation 0.05
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Total: Change at Week 52	-0.01 millimeter Standard Deviation 0.05	-0.01 millimeter Standard Deviation 0.06	0.00 millimeter Standard Deviation 0.05	0.01 millimeter Standard Deviation 0.06	0.01 millimeter Standard Deviation 0.05
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint Total: Change at Week 78	-0.01 millimeter Standard Deviation 0.05	0.00 millimeter Standard Deviation 0.06	0.06 millimeter Standard Deviation 0.06	0.02 millimeter Standard Deviation 0.07	0.03 millimeter Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline, Week 26, 52, 78 and 104

Population: Modified ITT analysis set was used. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" included those who were evaluable at specified timepoints.

The change in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint at Week 26, 52, 78 and 104 was calculated based on qMRI.

Outcome measures

Measure	Placebo n=94 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=97 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=97 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=96 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=99 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Medial: Change at Week 52	-10.2 microliter Standard Deviation 100.7	-2.9 microliter Standard Deviation 127.1	-7.0 microliter Standard Deviation 103.7	3.6 microliter Standard Deviation 127.5	16.5 microliter Standard Deviation 110.6
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Medial: Change at Week 78	-8.9 microliter Standard Deviation 125.3	-7.0 microliter Standard Deviation 153.7	23.6 microliter Standard Deviation 109.3	33.2 microliter Standard Deviation 177.0	53.9 microliter Standard Deviation 147.3
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Lateral: Change at Week 26	-12.8 microliter Standard Deviation 84.4	0.8 microliter Standard Deviation 82.0	1.5 microliter Standard Deviation 102.3	31.3 microliter Standard Deviation 87.7	25.1 microliter Standard Deviation 85.8
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Medial: Change at Week 26	0.0 microliter Standard Deviation 112.2	1.7 microliter Standard Deviation 110.8	-3.2 microliter Standard Deviation 99.5	16.7 microliter Standard Deviation 89.8	16.5 microliter Standard Deviation 114.2
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Medial: Change at Week 104	-41.0 microliter Standard Deviation 192.1	-21.4 microliter Standard Deviation 198.3	3.6 microliter Standard Deviation 123.9	19.5 microliter Standard Deviation 202.3	48.6 microliter Standard Deviation 150.7
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Lateral: Change at Week 52	-12.7 microliter Standard Deviation 94.0	-17.5 microliter Standard Deviation 141.1	2.7 microliter Standard Deviation 98.2	32.4 microliter Standard Deviation 107.5	28.1 microliter Standard Deviation 87.3
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Lateral: Change at Week 78	-1.8 microliter Standard Deviation 89.7	13.9 microliter Standard Deviation 113.6	21.6 microliter Standard Deviation 129.0	55.9 microliter Standard Deviation 123.1	55.2 microliter Standard Deviation 101.6
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Lateral: Change at Week 104	-14.5 microliter Standard Deviation 87.2	-6.8 microliter Standard Deviation 144.9	7.2 microliter Standard Deviation 134.8	75.5 microliter Standard Deviation 111.8	67.9 microliter Standard Deviation 112.5
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Total: Change at Week 26	-13.0 microliter Standard Deviation 163.2	2.5 microliter Standard Deviation 147.0	-2.9 microliter Standard Deviation 161.8	48.4 microliter Standard Deviation 150.9	41.5 microliter Standard Deviation 166.6
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Total: Change at Week 52	-23.7 microliter Standard Deviation 155.7	-20.4 microliter Standard Deviation 217.6	-5.5 microliter Standard Deviation 169.0	36.2 microliter Standard Deviation 203.1	44.7 microliter Standard Deviation 163.2
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Total: Change at Week 78	-10.3 microliter Standard Deviation 176.8	6.9 microliter Standard Deviation 228.1	44.8 microliter Standard Deviation 195.3	89.9 microliter Standard Deviation 272.6	109.1 microliter Standard Deviation 219.1
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 Total: Change at Week 104	-55.5 microliter Standard Deviation 239.5	-28.2 microliter Standard Deviation 275.7	9.5 microliter Standard Deviation 205.7	96.6 microliter Standard Deviation 271.1	116.5 microliter Standard Deviation 233.5

SECONDARY outcome

Timeframe: Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Arm assignments for participants in Safety Set were based on actual treatment received. Here "Number of Participants analyzed" = participants evaluable for this outcome measure and "Number analyzed" are those who were evaluable at specified timepoint.

Levels of sprifermin/FGF-18 in synovial fluid were measured to provide a first estimate of the residence time of sprifermin in the synovial fluid.

Outcome measures

Measure	Placebo n=3 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=20 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=22 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=25 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=27 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Synovial Fluid Levels of Sprifermin/FGF-18 Week 0; Cycle 1	—	56876.4 picogram/milliliter Interval 5843.8 to 86068.0	1006.5 picogram/milliliter Interval 206.6 to 34439.4	1386.1 picogram/milliliter Interval 260.4 to 36766.4	5896.4 picogram/milliliter Interval 631.3 to 238780.1
Synovial Fluid Levels of Sprifermin/FGF-18 Week 1; Cycle 1	622.1 picogram/milliliter Interval 156.0 to 1088.2	3628.3 picogram/milliliter Interval 229.9 to 37140.5	1493.2 picogram/milliliter Interval 214.2 to 110515.4	359.8 picogram/milliliter Interval 151.2 to 37014.8	1062.3 picogram/milliliter Interval 156.7 to 840122.2
Synovial Fluid Levels of Sprifermin/FGF-18 Week 2; Cycle 1	—	3150.9 picogram/milliliter Interval 189.1 to 33378.5	4167.0 picogram/milliliter Interval 460.3 to 8857.1	467.9 picogram/milliliter Interval 150.7 to 108866.0	258.2 picogram/milliliter Interval 171.9 to 48066.3
Synovial Fluid Levels of Sprifermin/FGF-18 Week 0; Cycle 2	202.5 picogram/milliliter Interval 202.5 to 202.5	—	7039.1 picogram/milliliter Interval 309.8 to 1108182.4	308.2 picogram/milliliter Interval 308.2 to 308.2	32360.2 picogram/milliliter Interval 559.9 to 683691.9
Synovial Fluid Levels of Sprifermin/FGF-18 Week 1; Cycle 2	—	—	14756.3 picogram/milliliter Interval 904.6 to 359059.2	—	7036.9 picogram/milliliter Interval 159.9 to 82301.6
Synovial Fluid Levels of Sprifermin/FGF-18 Week 2; Cycle 2	—	—	6408.3 picogram/milliliter Interval 154.4 to 220629.5	—	1146.7 picogram/milliliter Interval 156.1 to 42598.5
Synovial Fluid Levels of Sprifermin/FGF-18 Week 0; Cycle 3	463.7 picogram/milliliter Interval 223.8 to 5386.5	8019.3 picogram/milliliter Interval 279.2 to 358231.4	9443.4 picogram/milliliter Interval 505.7 to 271320.6	16901.2 picogram/milliliter Interval 461.0 to 273247.0	20753.0 picogram/milliliter Interval 4119.1 to 303440.5
Synovial Fluid Levels of Sprifermin/FGF-18 Week 1; Cycle 3	—	8607.6 picogram/milliliter Interval 276.7 to 147723.9	4605.1 picogram/milliliter Interval 337.2 to 358029.6	3908.8 picogram/milliliter Interval 177.5 to 86823.9	10160.0 picogram/milliliter Interval 165.5 to 375638.7
Synovial Fluid Levels of Sprifermin/FGF-18 Week 2; Cycle 3	260.9 picogram/milliliter Interval 260.9 to 260.9	9592.2 picogram/milliliter Interval 1277.1 to 35615.5	9422.2 picogram/milliliter Interval 409.3 to 353582.4	1801.0 picogram/milliliter Interval 171.9 to 77338.9	4161.7 picogram/milliliter Interval 151.1 to 213692.3
Synovial Fluid Levels of Sprifermin/FGF-18 Week 0; Cycle 4	—	—	12458.4 picogram/milliliter Interval 224.6 to 163129.3	—	22132.1 picogram/milliliter Interval 215.7 to 897758.2
Synovial Fluid Levels of Sprifermin/FGF-18 Week 1; Cycle 4	215.3 picogram/milliliter Interval 215.3 to 215.3	—	9602.7 picogram/milliliter Interval 178.6 to 45631.9	2285.2 picogram/milliliter Interval 2285.2 to 2285.2	11468.3 picogram/milliliter Interval 157.5 to 142318.7
Synovial Fluid Levels of Sprifermin/FGF-18 Week 2; Cycle 4	10670.0 picogram/milliliter Interval 10670.0 to 10670.0	—	7103.8 picogram/milliliter Interval 196.8 to 384511.5	331.1 picogram/milliliter Interval 168.4 to 493.7	8026.4 picogram/milliliter Interval 179.7 to 272804.6

SECONDARY outcome

Timeframe: Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days)

Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Arm assignments for participants in Safety Set were based on actual treatment received.

Outcome measures

Measure	Placebo n=107 Participants Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=109 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=111 Participants Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=111 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=109 Participants Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Serum Levels of Sprifermin/FGF-18	NA picogram/milliliter Standard Deviation NA Serum levels of AS902330/FGF-18 could not be analyzed because the serum concentrations were not quantifiable, as serum sprifermin concentrations were below Lower Limit of Quantification (LLOQ). LLOQ=100 picogram/milliliter.	NA picogram/milliliter Standard Deviation NA Serum levels of AS902330/FGF-18 could not be analyzed because the serum concentrations were not quantifiable, as serum sprifermin concentrations were below Lower Limit of Quantification (LLOQ). LLOQ=100 picogram/milliliter.	NA picogram/milliliter Standard Deviation NA Serum levels of AS902330/FGF-18 could not be analyzed because the serum concentrations were not quantifiable, as serum sprifermin concentrations were below Lower Limit of Quantification (LLOQ). LLOQ=100 picogram/milliliter.	NA picogram/milliliter Standard Deviation NA Serum levels of AS902330/FGF-18 could not be analyzed because the serum concentrations were not quantifiable, as serum sprifermin concentrations were below Lower Limit of Quantification (LLOQ). LLOQ=100 picogram/milliliter.	NA picogram/milliliter Standard Deviation NA Serum levels of AS902330/FGF-18 could not be analyzed because the serum concentrations were not quantifiable, as serum sprifermin concentrations were below Lower Limit of Quantification (LLOQ). LLOQ=100 picogram/milliliter.

Adverse Events

Placebo

Serious events: 39 serious events

Other events: 105 other events

Deaths: 1 deaths

Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles

Serious events: 35 serious events

Other events: 106 other events

Deaths: 0 deaths

Sprifermin (AS902330) 30 mcg- 4 Cycles

Serious events: 34 serious events

Other events: 109 other events

Deaths: 0 deaths

Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles)

Serious events: 32 serious events

Other events: 106 other events

Deaths: 0 deaths

Sprifermin (AS902330) 100 mcg- 4 Cycles

Serious events: 41 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=107 participants at risk Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=109 participants at risk Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=111 participants at risk Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=111 participants at risk Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=109 participants at risk Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Acute myocardial infarction	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Angina pectoris	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Atrial fibrillation	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Atrial flutter	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Coronary artery stenosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Myocardial infarction	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Angina unstable	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Cardiac failure congestive	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Myocardial ischaemia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Aortic valve stenosis	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Arrhythmia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Bradycardia	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Cardiac failure	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Cardiomyopathy	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Pericarditis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Stress cardiomyopathy	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Ventricular extrasystoles	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Cardiac disorders Ventricular tachycardia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Ear and labyrinth disorders Vertigo	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Ear and labyrinth disorders Vertigo positional	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Endocrine disorders Toxic nodular goitre	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Eye disorders Retinal detachment	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Gastritis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Large intestine polyp	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Colitis	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Diverticulum	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Gastric ulcer	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Haemorrhoids	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Ileus	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Loose tooth	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Arthritis bacterial	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Umbilical hernia	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
General disorders Chest pain	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
General disorders Malaise	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
General disorders Non-cardiac chest pain	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
General disorders Peripheral swelling	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Hepatobiliary disorders Cholecystitis	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Cellulitis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Hepatobiliary disorders Cholelithiasis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Hepatobiliary disorders Bile duct stone	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Hepatobiliary disorders Cholangitis acute	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Pneumonia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Urinary tract infection	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Appendicitis	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Bronchitis	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Cystitis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Diverticulitis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Erysipelas	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Gastroenteritis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Influenza	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Lower respiratory tract infection	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Otitis media chronic	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Sialoadenitis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Tonsillitis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Urosepsis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Meniscus injury	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Contusion	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Concussion	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Head injury	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Muscle strain	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Pelvic fracture	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Skin injury	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	8.4% 9/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.2% 10/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Chondropathy	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Synovitis	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Brain stem infarction	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Trigger finger	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the gastrointestinal tract	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Cerebrovascular accident	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Sciatica	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Syncope	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Arachnoid cyst	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Carpal tunnel syndrom	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Cerebral ischaemia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Cubital tunnel syndrome	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Dizziness	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Haemorrhagic stroke	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Meningeal disorder	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Transient ischaemic attack	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Trigeminal neuralgia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Product Issues Device dislocation	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Psychiatric disorders Depression	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Renal and urinary disorders Urinary retention	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Renal and urinary disorders Haematuria	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Renal and urinary disorders Renal infarct	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Reproductive system and breast disorders Colpocele	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Reproductive system and breast disorders Uterine polyp	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Reproductive system and breast disorders Vulvar dysplasia	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Surgical and medical procedures Removal of internal fixation	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Hypertension	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Aortic aneurysm	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Aortic stenosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Deep vein thrombosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Peripheral artery thrombosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Thrombosis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Varicose vein	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.

Other adverse events

Measure	Placebo n=107 participants at risk Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles n=109 participants at risk Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 30 mcg- 4 Cycles n=111 participants at risk Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) n=111 participants at risk Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.	Sprifermin (AS902330) 100 mcg- 4 Cycles n=109 participants at risk Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Musculoskeletal and connective tissue disorders Neck pain	6.5% 7/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.1% 9/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.1% 9/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Spinal pain	4.7% 5/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.5% 5/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.2% 10/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 6/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.2% 10/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Myalgia	3.7% 4/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.2% 8/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Periarthritis	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.3% 8/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.5% 5/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.5% 5/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Plantar fasciitis	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Tendonitis	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.3% 8/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Arthritis	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Headache	14.0% 15/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	12.8% 14/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.9% 11/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	11.7% 13/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	16.5% 18/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Sciatica	10.3% 11/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.3% 8/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Dizziness	6.5% 7/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.5% 5/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.2% 10/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Hypoaesthesia	6.5% 7/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.5% 5/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Nervous system disorders Memory impairment	3.7% 4/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Psychiatric disorders Insomnia	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	8.4% 9/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	11.0% 12/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	10.8% 12/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.3% 9/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.5% 7/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Vascular disorders Hypertension	15.9% 17/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	22.0% 24/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	12.6% 14/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	18.0% 20/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	19.3% 21/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Endocrine disorders Hypothyroidism	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.92% 1/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Eye disorders Cataract	7.5% 8/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.0% 10/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Abdominal pain upper	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Diarrhoea	1.9% 2/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.2% 8/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Gastritis	3.7% 4/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Toothache	4.7% 5/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Dyspepsia	3.7% 4/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.90% 1/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Gastrointestinal disorders Abdominal pain	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
General disorders Injection site pain	5.6% 6/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.0% 10/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.3% 8/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
General disorders Injection site bruising	3.7% 4/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Upper respiratory tract infection	19.6% 21/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	22.9% 25/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	25.2% 28/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	25.2% 28/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	27.5% 30/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Nasopharyngitis	25.2% 27/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	22.9% 25/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	18.0% 20/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	17.1% 19/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	20.2% 22/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Urinary tract infection	9.3% 10/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	11.9% 13/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.0% 10/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	11.7% 13/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	15.6% 17/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Influenza	12.1% 13/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.2% 10/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.9% 11/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	10.8% 12/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	11.0% 12/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Cystitis	6.5% 7/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	13.8% 15/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.2% 8/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.1% 9/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.2% 10/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Bronchitis	9.3% 10/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	10.1% 11/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.3% 9/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Pneumonia	5.6% 6/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.3% 9/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Viral infection	4.7% 5/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.7% 4/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Gastroenteritis	0.00% 0/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Infections and infestations Herpes zoster	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Procedural pain	16.8% 18/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.3% 9/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.1% 9/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.1% 9/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Contusion	4.7% 5/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.3% 9/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.1% 9/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	8.3% 9/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Ligament sprain	5.6% 6/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	7.3% 8/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Injury, poisoning and procedural complications Skin abrasion	0.93% 1/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.3% 7/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Investigations C-reactive protein increased	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	0.00% 0/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Metabolism and nutrition disorders Hypercholesterolaemia	3.7% 4/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	4.6% 5/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.0% 10/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Metabolism and nutrition disorders Hyperlipidaemia	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	6.4% 7/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	3.6% 4/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	1.8% 2/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Metabolism and nutrition disorders Diabetes mellitus	2.8% 3/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.5% 6/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.7% 3/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	5.4% 6/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	2.8% 3/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	54.2% 58/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	54.1% 59/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	51.4% 57/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	49.5% 55/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	49.5% 54/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Back pain	22.4% 24/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	25.7% 28/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	26.1% 29/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	29.7% 33/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	24.8% 27/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	19.6% 21/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	20.2% 22/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	21.6% 24/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	15.3% 17/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	15.6% 17/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	18.7% 20/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	14.7% 16/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	16.2% 18/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	18.9% 21/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	19.3% 21/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	14.0% 15/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	11.0% 12/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	21.6% 24/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	16.2% 18/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	18.3% 20/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.
Musculoskeletal and connective tissue disorders Joint swelling	9.3% 10/107 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	12.8% 14/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	9.9% 11/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	10.8% 12/111 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.	12.8% 14/109 • Baseline up to 5 years. Participants were assessed for adverse events for the entire study. Adverse events are presented as per Safety Set.Arm assignments for participants in Safety Set were based on actual treatment received, such that 1participant assigned to Placebo arm who inadvertently received 30 mcg was included in Sprifermin 30mcg/placebo-2 Cycles arm for purpose of safety analysis. Similarly, 1 participant assigned to Sprifermin 30mcg/placebo-2 Cycles arm who inadvertently received 100 mcg was included in Sprifermin 100mcg/placebo-2 Cycles arm for purpose of safety analysis.

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: service@emdgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place