Trial Outcomes & Findings for Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change (NCT NCT00119067)

NCT ID: NCT00119067

Last Updated: 2024-05-29

Results Overview

warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. The number of injections analyzable varies for each event based on the presence or absence of reported data.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1564 participants

Primary outcome timeframe

4 weeks after each injection

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Anthrax Vaccine Adsorbed 8-SQ receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 8-IM receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 7-IM receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 5-IM receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 4-IM receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42 Anthrax Vaccine Adsorbed	Saline Placebo IM or SQ Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Overall Study STARTED	260	262	256	258	268	260
Overall Study COMPLETED	148	157	146	144	158	144
Overall Study NOT COMPLETED	112	105	110	114	110	116

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anthrax Vaccine Adsorbed 8-SQ n=259 Participants receive 8 injections of Anthrax Vaccine Adsorbed injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.	Anthrax Vaccine Adsorbed 8-IM n=262 Participants receive 8 injections of Anthrax Vaccine Adsorbed IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.	Anthrax Vaccine Adsorbed 7-IM n=256 Participants receive 7 injections of Anthrax Vaccine Adsorbed IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.	Anthrax Vaccine Adsorbed 5-IM n=258 Participants receive 5 injections of Anthrax Vaccine Adsorbed IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.	Anthrax Vaccine Adsorbed 4-IM n=268 Participants receive 4 injections of Anthrax Vaccine Adsorbed IM; months 0, 2, 6 and a booster at month 42	Saline Placebo IM or SQ n=260 Participants Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.	Total n=1563 Participants Total of all reporting groups
Age, Customized Age <30	77 participants n=5 Participants	63 participants n=7 Participants	75 participants n=5 Participants	77 participants n=4 Participants	72 participants n=21 Participants	75 participants n=10 Participants	439 participants n=115 Participants
Age, Customized Age 30-39	42 participants n=5 Participants	57 participants n=7 Participants	77 participants n=5 Participants	65 participants n=4 Participants	60 participants n=21 Participants	60 participants n=10 Participants	361 participants n=115 Participants
Age, Customized Age 40-49	91 participants n=5 Participants	87 participants n=7 Participants	54 participants n=5 Participants	64 participants n=4 Participants	91 participants n=21 Participants	73 participants n=10 Participants	460 participants n=115 Participants
Age, Customized Age 50-61	49 participants n=5 Participants	55 participants n=7 Participants	50 participants n=5 Participants	52 participants n=4 Participants	45 participants n=21 Participants	52 participants n=10 Participants	303 participants n=115 Participants
Sex: Female, Male Female	134 Participants n=5 Participants	135 Participants n=7 Participants	132 Participants n=5 Participants	131 Participants n=4 Participants	136 Participants n=21 Participants	132 Participants n=10 Participants	800 Participants n=115 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	127 Participants n=7 Participants	124 Participants n=5 Participants	127 Participants n=4 Participants	132 Participants n=21 Participants	128 Participants n=10 Participants	763 Participants n=115 Participants
Race/Ethnicity, Customized Race: White	199 participants n=5 Participants	197 participants n=7 Participants	194 participants n=5 Participants	183 participants n=4 Participants	201 participants n=21 Participants	185 participants n=10 Participants	1159 participants n=115 Participants
Race/Ethnicity, Customized Race: Black	47 participants n=5 Participants	48 participants n=7 Participants	49 participants n=5 Participants	62 participants n=4 Participants	59 participants n=21 Participants	59 participants n=10 Participants	324 participants n=115 Participants
Race/Ethnicity, Customized Race: Other	13 participants n=5 Participants	17 participants n=7 Participants	13 participants n=5 Participants	13 participants n=4 Participants	8 participants n=21 Participants	16 participants n=10 Participants	80 participants n=115 Participants
Race/Ethnicity, Customized Ethnicity:Non-Hispanic	246 participants n=5 Participants	250 participants n=7 Participants	247 participants n=5 Participants	243 participants n=4 Participants	256 participants n=21 Participants	251 participants n=10 Participants	1493 participants n=115 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic	13 participants n=5 Participants	12 participants n=7 Participants	9 participants n=5 Participants	15 participants n=4 Participants	12 participants n=21 Participants	9 participants n=10 Participants	70 participants n=115 Participants

PRIMARY outcome

Timeframe: 4 weeks after each injection

Population: There are missing data

Outcome measures

Outcome measures
Measure	SQ Females n=958 Number of doses received female participants receiving SQ AVA injection	IM Female n=2806 Number of doses received female participants receiving IM AVA injection	SQ Males n=835 Number of doses received male participants receiving SQ AVA injection	IM Male n=2584 Number of doses received male participants receiving IM AVA injection	Anthrax Vaccine Adsorbed 4-IM receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 754-IM The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	Saline Placebo IM or SQ Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Local AEs Warmth	500 injections	344 injections	186 injections	189 injections	—	—	—
Local AEs Tenderness	667 injections	1398 injections	410 injections	1075 injections	—	—	—
Local AEs Edema	345 injections	528 injections	225 injections	354 injections	—	—	—
Local AEs Itching	247 injections	160 injections	80 injections	77 injections	—	—	—
Local AEs Pain	201 injections	569 injections	96 injections	341 injections	—	—	—
Local AEs Arm Motion Limitation	94 injections	434 injections	50 injections	218 injections	—	—	—
Local AEs Erythema	723 injections	952 injections	399 injections	603 injections	—	—	—
Local AEs Induration	411 injections	386 injections	195 injections	245 injections	—	—	—
Local AEs Nodules	409 injections	161 injections	133 injections	98 injections	—	—	—
Local AEs Bruise	69 injections	150 injections	65 injections	32 injections	—	—	—

PRIMARY outcome

Timeframe: 4 weeks after each injection

Population: We analyzed by number of doses received. There might be missing data; people dropped out as time went on

Fatigue, Muscle Ache, Headache, Fever, Tender Axillary Lymphnode The number of injections analyzable varies for each event based on the presence or absence of reported data.

Outcome measures

Outcome measures
Measure	SQ Females n=958 Number of doses received female participants receiving SQ AVA injection	IM Female n=2806 Number of doses received female participants receiving IM AVA injection	SQ Males n=835 Number of doses received male participants receiving SQ AVA injection	IM Male n=2584 Number of doses received male participants receiving IM AVA injection	Anthrax Vaccine Adsorbed 4-IM receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 754-IM The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	Saline Placebo IM or SQ Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Systemic AEs Fatigue	118 injections	278 injections	69 injections	182 injections	—	—	—
Systemic AEs Tender Axillary Adenopathy	10 injections	17 injections	3 injections	8 injections	—	—	—
Systemic AEs Muscle Ache	57 injections	226 injections	36 injections	132 injections	—	—	—
Systemic AEs Headache	90 injections	219 injections	39 injections	105 injections	—	—	—
Systemic AEs Fever	0 injections	0 injections	0 injections	1 injections	—	—	—

PRIMARY outcome

Timeframe: 4 weeks after the m1, m6 and m42 injections

Geometric mean of the Anti-PA IgG Concentration measured in μg/mL. The lower limit of quantification (LLOQ) is 3.7, results below the LLOQ have been replaced by 1/2 LLOQ (1.85) before taking the geometric mean.

Outcome measures

Outcome measures
Measure	SQ Females n=235 Participants female participants receiving SQ AVA injection	IM Female n=234 Participants female participants receiving IM AVA injection	SQ Males n=139 Participants male participants receiving SQ AVA injection	IM Male n=141 Participants male participants receiving IM AVA injection	Anthrax Vaccine Adsorbed 4-IM n=157 Participants receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 754-IM n=698 Participants The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	Saline Placebo IM or SQ n=243 Participants Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Anti-protective Antigen IgG Geometric Mean Concentration Month 7	201.1 μg/ml Interval 174.7 to 231.6	232.6 μg/ml Interval 202.4 to 267.3	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	206.9 μg/ml Interval 187.1 to 227.0	1.9 μg/ml Interval 1.9 to 2.0
Anti-protective Antigen IgG Geometric Mean Concentration Month 43	216.8 μg/ml Interval 185.8 to 253.1	320.5 μg/ml Interval 276.0 to 372.1	254.8 μg/ml Interval 222.0 to 292.4	310.0 μg/ml Interval 270.5 to 355.3	433.2 μg/ml Interval 379.6 to 494.4	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	1.9 μg/ml Interval 1.8 to 1.9
Anti-protective Antigen IgG Geometric Mean Concentration Month 2	94.3 μg/ml Interval 82.1 to 108.3	84.5 μg/ml Interval 73.7 to 96.8	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA μg/ml The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	46.4 μg/ml Interval 42.2 to 51.0	1.9 μg/ml Interval 1.9 to 2.0

PRIMARY outcome

Timeframe: 4 weeks after the m1, m6 and m42 injections

Geometric mean of the Dilutional Titer. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by 1/2 LLOQ (29) before taking the geometric mean.

Outcome measures

Outcome measures
Measure	SQ Females n=235 Participants female participants receiving SQ AVA injection	IM Female n=234 Participants female participants receiving IM AVA injection	SQ Males n=139 Participants male participants receiving SQ AVA injection	IM Male n=141 Participants male participants receiving IM AVA injection	Anthrax Vaccine Adsorbed 4-IM n=157 Participants receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 754-IM n=698 Participants The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	Saline Placebo IM or SQ n=243 Participants Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Anti-protective Antigen IgG Geometric Mean Titer Month 2	1048.5 Dilutional Titer Interval 913.1 to 1204.1	934.8 Dilutional Titer Interval 815.6 to 1071.3	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	514.6 Dilutional Titer Interval 468.1 to 565.7	29.7 Dilutional Titer Interval 28.7 to 30.6
Anti-protective Antigen IgG Geometric Mean Titer Month 7	2211.9 Dilutional Titer Interval 1921.8 to 2545.9	2545.6 Dilutional Titer Interval 2215.1 to 2925.1	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	2257.0 Dilutional Titer Interval 2050.1 to 2484.9	29.7 Dilutional Titer Interval 28.7 to 30.8
Anti-protective Antigen IgG Geometric Mean Titer Month 43	2282.4 Dilutional Titer Interval 1955.8 to 2663.5	3425.4 Dilutional Titer Interval 2950.4 to 3976.9	2760.4 Dilutional Titer Interval 2404.7 to 3168.6	3286.4 Dilutional Titer Interval 2866.5 to 3767.8	4683.8 Dilutional Titer Interval 4103.0 to 5346.8	NA Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	29.0 Dilutional Titer Interval 29.0 to 29.0

PRIMARY outcome

Timeframe: 4 weeks after the m1, m6 and m42 injections

Percent of participants who achieved a 4-fold or greater rise in anti-PA IgG Titer relative to the pre-vaccination level at month 0. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by LLOQ (58) before calculating the fold response. Thus the lowest titer that can achieve 4-fold rise is 4\*58 = 232.

Outcome measures

Outcome measures
Measure	SQ Females n=235 Participants female participants receiving SQ AVA injection	IM Female n=234 Participants female participants receiving IM AVA injection	SQ Males n=139 Participants male participants receiving SQ AVA injection	IM Male n=141 Participants male participants receiving IM AVA injection	Anthrax Vaccine Adsorbed 4-IM n=157 Participants receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 754-IM n=698 Participants The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	Saline Placebo IM or SQ n=243 Participants Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
4-fold Rise in Anti-protective Antigen IgG Titer Response Month 43	100.0 % of participants with ≥4-fold rise Interval 97.5 to 100.0	100.0 % of participants with ≥4-fold rise Interval 97.7 to 100.0	100.0 % of participants with ≥4-fold rise Interval 97.4 to 100.0	99.3 % of participants with ≥4-fold rise Interval 96.1 to 100.0	99.4 % of participants with ≥4-fold rise Interval 96.5 to 100.0	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	0.0 % of participants with ≥4-fold rise Interval 0.0 to 2.6
4-fold Rise in Anti-protective Antigen IgG Titer Response Month 2	94.9 % of participants with ≥4-fold rise Interval 91.3 to 97.3	91.9 % of participants with ≥4-fold rise Interval 87.6 to 95.0	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	78.8 % of participants with ≥4-fold rise Interval 75.6 to 81.8	0.4 % of participants with ≥4-fold rise Interval 0.01 to 2.3
4-fold Rise in Anti-protective Antigen IgG Titer Response Month 7	98.6 % of participants with ≥4-fold rise Interval 96.1 to 99.7	98.6 % of participants with ≥4-fold rise Interval 96.0 to 99.7	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA % of participants with ≥4-fold rise The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	97.8 % of participants with ≥4-fold rise Interval 96.3 to 99.0	0.5 % of participants with ≥4-fold rise Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 4 weeks after the m1, m6 and m42 injections

Geometric mean of the ED50. The ED50 is the reciprocal of the dilution at which patient serum neutralizes 50% of a dose of anthrax lethal toxin (ED50). The lower limit of quantification (LLOQ) for this assay is 36, results below the LLOQ have been replaced with 1/2 LLOQ (18) before taking the geometric mean. Note that this secondary endpoint was only performed on \~47% of the participants.

Outcome measures

Outcome measures
Measure	SQ Females n=112 Participants female participants receiving SQ AVA injection	IM Female n=103 Participants female participants receiving IM AVA injection	SQ Males n=56 Participants male participants receiving SQ AVA injection	IM Male n=67 Participants male participants receiving IM AVA injection	Anthrax Vaccine Adsorbed 4-IM n=66 Participants receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m. Anthrax Vaccine Adsorbed	Anthrax Vaccine Adsorbed 754-IM n=315 Participants The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	Saline Placebo IM or SQ n=124 Participants Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
TNA ED50 Titer Month 7	1281.1 ED50 Dilutional Titer Interval 1073.9 to 1528.3	1630.0 ED50 Dilutional Titer Interval 1354.3 to 1961.7	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	1423.9 ED50 Dilutional Titer Interval 1253.1 to 1617.9	18.1 ED50 Dilutional Titer Interval 17.9 to 18.4
TNA ED50 Titer Month 2	229.1 ED50 Dilutional Titer Interval 190.9 to 274.9	240.8 ED50 Dilutional Titer Interval 196.5 to 295.2	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	165.5 ED50 Dilutional Titer Interval 146.2 to 187.4	18.0 ED50 Dilutional Titer Interval 18.0 to 18.0
TNA ED50 Titer Month 43	1015.0 ED50 Dilutional Titer Interval 827.8 to 1244.4	1540.3 ED50 Dilutional Titer Interval 1274.6 to 1861.4	1451.0 ED50 Dilutional Titer Interval 1139.5 to 1847.7	1876.2 ED50 Dilutional Titer Interval 1603.1 to 2195.9	2825.9 ED50 Dilutional Titer Interval 2175.2 to 3671.3	NA ED50 Dilutional Titer The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.	18.0 ED50 Dilutional Titer Interval 18.0 to 18.0

Adverse Events

8-SQ

Serious events: 26 serious events

Other events: 254 other events

Deaths: 0 deaths

8-IM

Serious events: 35 serious events

Other events: 250 other events

Deaths: 3 deaths

7-IM

Serious events: 27 serious events

Other events: 249 other events

Deaths: 2 deaths

5-IM AVA

Serious events: 35 serious events

Other events: 253 other events

Deaths: 1 deaths

4-IM

Serious events: 38 serious events

Other events: 263 other events

Deaths: 0 deaths

Saline Placebo

Serious events: 27 serious events

Other events: 200 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	8-SQ n=259 participants at risk 8 AVA injections administered subcutaneously at months 0, 0.5, 1, 6, 12, 18, 30, and 42 (the initially licensed schedule and route)	8-IM n=262 participants at risk 8 AVA injections administered intramuscularly at months 0, 0.5, 1, 6, 12, 18, 30, and 42	7-IM n=256 participants at risk 7 AVA injections administered intramuscularly at months 0, 1, 6, 12, 18, 30, and 42	5-IM AVA n=258 participants at risk 5 AVA injections administered intramuscularly at months 0, 1, 6, 18, and 42	4-IM n=268 participants at risk 4 AVA injections administered intramuscularly at months 0, 1, 6, and 42	Saline Placebo n=260 participants at risk 8 saline placebo injections administered subcutaneously or intramuscularly at months 0, 0.5, 1, 6, 12, 18, 30, and 42. Placebo participants were grouped for analysis regardless of injection route
Cardiac disorders Death due to atherosclerosis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders muscle, tendon, or ligament tear/rupture	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/258 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.1% 3/268 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Immune system disorders Generalized allergic reaction	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders Bilateral pseudotumor cerebri	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders Hydrocephalus and aqueductal stenosis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) breast cancer	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations Pneumocystis carinii	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Lymphoma	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.77% 2/259 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.2% 3/260 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell carcinoma	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.2% 3/256 • Number of events 4 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/258 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/268 • Number of events 10 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/260 • Number of events 5 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) pancreatic cancer	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders cellulitis, hospitalized	0.77% 2/259 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.75% 2/268 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders Embolization secondary to AV malformation	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) melanoma	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.77% 2/260 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders gastroenteritis	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders Prostate Cancer	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Skin and subcutaneous tissue disorders burns	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures appendectomy secondary to appendicitis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.1% 3/268 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.2% 3/260 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders intestinal obstruction	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/258 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Immune system disorders Systemic Lupus Erythematosus/positive ANA	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders Traumatic Brain Injury	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders miscarriage/spontaneous abortion	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/258 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.1% 3/268 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Renal and urinary disorders pyelonephritis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.76% 2/262 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures Ceasarian section with healthy infant delivery	1.2% 3/259 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.76% 2/262 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/258 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.75% 2/268 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures surgical repair of cystocele, vaginocele, rectocele	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders sick sinus syndrome	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Pregnancy, puerperium and perinatal conditions premature labor; delivery of healthy infant	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Renal and urinary disorders Kidney Stone(s)	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders bypass surgery	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Hepatobiliary disorders Chronic Hepatitis B	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations meningitis (viral)	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Ear and labyrinth disorders Acoustic Neuroma	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders Hospitalized for alcohol dependence/rehabilitation	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.75% 2/268 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures Angioplasty and stent placement	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Skin and subcutaneous tissue disorders staph infection secondary to poison ivy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Immune system disorders sarcoidosis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders anemia	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroidectomy secondary to thyroid papillary carcinoma	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications bone fracture(s) following accident	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.6% 4/258 • Number of events 4 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications injury after falling	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.76% 2/262 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders acute psychosis and schizophrenia	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders bacterial endocarditis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) benign ovarian teratoma	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures lumbar diskectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders Hospitalized for mental disorder	1.2% 3/259 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.5% 4/262 • Number of events 5 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.5% 4/260 • Number of events 4 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Vascular disorders blood clot	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures breast reduction	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures cardiac catheritization	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Hepatobiliary disorders Cholecystitis	1.2% 3/259 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/256 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications head injury following motor vehicle accident	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders hospitalized for drug overdose	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Eye disorders corneal ulcer/iritis	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Pregnancy, puerperium and perinatal conditions c-section; delivery of infant with bilateral congenital hip dysplasia	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Pregnancy, puerperium and perinatal conditions C-section; infant with hydrocephalus and jaundice	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Pregnancy, puerperium and perinatal conditions c-section; infant with jaundice	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations death secondary to AIDS	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders death due to suicide	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications death due to gunshot wound	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Vascular disorders death due to aneurnysm rupture	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications death due to fall	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications death following motor vehicle accident	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Vascular disorders deep vein thrombosis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders dehydration secondary to other cause	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Pregnancy, puerperium and perinatal conditions delivery of infant with right club foot deformity	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Pregnancy, puerperium and perinatal conditions delivery of healthy twins	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Hepatobiliary disorders diverticulitis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures abdominoplasty	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders esophageal tear	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders erosive esophagitis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders GI ulcers and bleeding	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders ventral hernia and repair	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Endocrine disorders hypothyroid following radioactive idodine treatment for Graves' disease	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders syncope with hypotension	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures hysterectomy and salpingooophorectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures hysterectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures laminectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders Coronary Artery Disease	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.76% 2/262 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.78% 2/258 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders atrial Fibrillation secondary to Mitral Valve Stenosis	0.39% 1/259 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders myocardial infarction	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders Hospitalized; non-specific symptoms	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders pancreatitis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Social circumstances Partial paralysis following gunshot wound to head	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders Pelvic Inflammatory Disease	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) pituitary mass	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations possible C.difficile	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Immune system disorders possible multiple sclerosis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures post surgical complications	0.77% 2/259 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations abscess	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures Laparoscopic Lyses of Adhesions due to intestinal obstructions	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures prostatectomy	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Eye disorders retinal tear	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) intrarenal malignancy	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders seizures	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders shoulder impingement and correction	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures sinus reconstruction	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications spleen laceration following motor vehicle accident	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Stage IV Non Hodgkins Lymphoma, B cell intermediate grade	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders cardioconversion to correct atrial flutter with supraventricular tachycardia	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders Uncontrolled Hypertension	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders uncontrolled diabetes and syncope	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders uterine fibroids	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.77% 2/260 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures cholecystectomy	0.77% 2/259 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.2% 3/256 • Number of events 3 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures Lumpectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastasis of pancreatic adenocarcinoma	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures hemicolectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures pacemaker implatation	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures pancreatectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures lumpectomy/mastectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Skin and subcutaneous tissue disorders cellulitis, not hospitalized	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 2 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures panniculectomy	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures nephrectomy	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders osteomyelitis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures mitral valve replacement	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures aortic valve replacement	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures removal of vegetations due to endocarditis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders atrioventricular block	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders dysmenorrhea	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures vertebral fusion	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders avascular necrosis of hip	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures hip arthroplasty	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders gastroesophageal reflux leading to abnormal EKG and chest pain	0.39% 1/259 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Renal and urinary disorders urosepsis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations HIV positive	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders hospitalized; chest pain	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders hospitalized, back pain evaluation	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/260 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders ventriculostomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Cardiac disorders transient ischemia	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.37% 1/268 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders benign ovarian cysts	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders Leiomyomata	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders adenomyosis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/256 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Surgical and medical procedures hysterectomy plus oophorectomy	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders rhabdomyolysis	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.39% 1/258 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications multiple injuries following motor vehicle accident	0.00% 0/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.38% 1/262 • Number of events 1 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	0.00% 0/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.

Other adverse events

Other adverse events
Measure	8-SQ n=259 participants at risk 8 AVA injections administered subcutaneously at months 0, 0.5, 1, 6, 12, 18, 30, and 42 (the initially licensed schedule and route)	8-IM n=262 participants at risk 8 AVA injections administered intramuscularly at months 0, 0.5, 1, 6, 12, 18, 30, and 42	7-IM n=256 participants at risk 7 AVA injections administered intramuscularly at months 0, 1, 6, 12, 18, 30, and 42	5-IM AVA n=258 participants at risk 5 AVA injections administered intramuscularly at months 0, 1, 6, 18, and 42	4-IM n=268 participants at risk 4 AVA injections administered intramuscularly at months 0, 1, 6, and 42	Saline Placebo n=260 participants at risk 8 saline placebo injections administered subcutaneously or intramuscularly at months 0, 0.5, 1, 6, 12, 18, 30, and 42. Placebo participants were grouped for analysis regardless of injection route
Blood and lymphatic system disorders LYMPHADENOPATHY	3.1% 8/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.5% 4/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.3% 6/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.2% 16/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.6% 7/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders ABDOMINAL PAIN NOS	3.5% 9/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.1% 8/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.1% 8/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.3% 6/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.7% 18/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.5% 4/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders DIARRHOEA NOS	10.4% 27/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.5% 25/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.8% 20/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.1% 21/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.6% 23/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.7% 20/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders DYSPEPSIA	6.2% 16/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.6% 12/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.2% 16/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.3% 25/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.1% 21/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	5.0% 13/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.1% 8/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.1% 8/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.5% 9/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.5% 12/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders NAUSEA	12.0% 31/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.9% 26/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.6% 22/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.7% 25/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	13.4% 36/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.0% 26/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders TOOTHACHE	5.4% 14/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.1% 16/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.3% 11/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.1% 8/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.1% 11/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.2% 11/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Gastrointestinal disorders VOMITING NOS	5.0% 13/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.1% 16/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.7% 12/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.0% 8/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.8% 10/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders FATIGUE	76.8% 199/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	71.4% 187/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	73.0% 187/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	68.6% 177/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	67.5% 181/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	60.8% 158/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE BRUISING	57.9% 150/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	38.5% 101/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	33.2% 85/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	39.1% 101/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	29.9% 80/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	28.5% 74/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE ERYTHEMA	94.2% 244/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	79.8% 209/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	80.9% 207/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	72.5% 187/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	72.8% 195/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	52.7% 137/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE JOINT MOVEMENT IMPAIRMENT	62.9% 163/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	68.3% 179/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	69.1% 177/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	68.2% 176/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	70.1% 188/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	16.2% 42/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE PAIN	87.3% 226/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	85.1% 223/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	87.5% 224/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	85.7% 221/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	82.8% 222/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	32.3% 84/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE PRURITUS	71.8% 186/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	43.5% 114/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	39.5% 101/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	27.5% 71/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	27.2% 73/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	12.3% 32/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE SWELLING / LUMP	95.8% 248/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	82.1% 215/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	85.2% 218/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	77.5% 200/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	68.7% 184/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	46.2% 120/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE TENDERNESS	96.9% 251/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	92.0% 241/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	94.9% 243/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	91.9% 237/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	91.0% 244/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	42.3% 110/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders INJECTION SITE WARMTH	86.1% 223/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	58.8% 154/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	54.7% 140/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	47.3% 122/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	39.6% 106/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	13.8% 36/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
General disorders PYREXIA	14.7% 38/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	11.1% 29/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.2% 21/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.1% 26/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.8% 21/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.6% 25/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Immune system disorders HYPERSENSITIVITY NOS	4.2% 11/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.3% 14/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.1% 13/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.4% 14/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.6% 7/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.5% 9/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations INFLUENZA	5.4% 14/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.4% 9/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.5% 9/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.4% 14/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.2% 14/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.5% 17/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations NASOPHARYNGITIS	24.7% 64/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	23.3% 61/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	22.7% 58/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	22.9% 59/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	23.1% 62/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	21.5% 56/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations SINUSITIS NOS	12.7% 33/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	13.7% 36/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.8% 25/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	11.6% 30/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	12.7% 34/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.5% 22/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION NOS	12.0% 31/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.8% 23/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	12.5% 32/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.3% 24/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.3% 25/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Infections and infestations URINARY TRACT INFECTION NOS	3.5% 9/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.9% 15/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.5% 9/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.0% 8/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.8% 23/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications JOINT SPRAIN	5.4% 14/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.7% 12/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.5% 9/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.6% 7/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.6% 12/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications LIMB INJURY NOS	4.2% 11/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.1% 13/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.7% 12/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.5% 12/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.6% 12/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Injury, poisoning and procedural complications POST PROCEDURAL PAIN	8.5% 22/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.9% 18/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.9% 15/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.8% 21/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.1% 21/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	4.2% 11/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.5% 17/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.5% 9/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.7% 12/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.2% 6/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders ARTHRALGIA	22.0% 57/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	19.1% 50/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	17.6% 45/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	19.4% 50/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	19.4% 52/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	16.9% 44/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders BACK PAIN	16.6% 43/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	17.6% 46/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	16.4% 42/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	16.7% 43/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	19.0% 51/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	14.6% 38/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	3.5% 9/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.1% 3/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.0% 5/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.4% 14/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.0% 8/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders MYALGIA	76.1% 197/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	70.6% 185/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	73.4% 188/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	72.1% 186/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	72.8% 195/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	50.0% 130/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders NECK PAIN	6.2% 16/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.3% 14/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.3% 11/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.8% 20/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.1% 19/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.8% 10/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	7.3% 19/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.9% 26/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.5% 27/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.3% 24/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.4% 28/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders DIZZINESS	6.6% 17/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.2% 11/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.0% 5/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.9% 10/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.2% 14/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.1% 8/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Nervous system disorders HEADACHE	78.4% 203/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	66.0% 173/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	75.8% 194/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	70.2% 181/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	69.8% 187/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	68.1% 177/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders ANXIETY	3.1% 8/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.2% 14/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders DEPRESSION	6.9% 18/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.8% 10/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.6% 17/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.4% 14/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.6% 15/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.6% 12/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Psychiatric disorders INSOMNIA	4.2% 11/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.8% 23/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.0% 18/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.4% 14/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.6% 15/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.6% 12/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Reproductive system and breast disorders DYSMENORRHOEA	8.5% 22/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.0% 21/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.5% 27/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.6% 17/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	11.2% 30/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.6% 25/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders BRONCHITIS NOS	6.6% 17/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.8% 10/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.2% 16/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.0% 18/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.0% 16/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders COUGH	12.4% 32/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	9.9% 26/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.9% 28/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	12.0% 31/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	13.1% 35/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.4% 27/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	9.7% 25/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.6% 20/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.2% 16/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	10.9% 28/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.1% 19/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	20.5% 53/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	17.9% 47/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	12.5% 32/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	20.5% 53/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	17.5% 47/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	14.2% 37/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	3.1% 8/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.7% 12/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.9% 13/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders RHINITIS NOS	5.0% 13/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.6% 20/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.3% 11/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.6% 15/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.4% 14/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	7.3% 19/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.2% 11/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.5% 14/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	8.9% 23/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.8% 21/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	3.1% 8/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.0% 13/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.9% 10/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.7% 7/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.2% 14/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.2% 11/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Skin and subcutaneous tissue disorders PRURITUS	5.0% 13/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.0% 5/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.9% 10/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	3.0% 8/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	1.9% 5/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Skin and subcutaneous tissue disorders RASH NOS	6.9% 18/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.6% 12/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	4.7% 12/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.3% 6/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.2% 14/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	2.3% 6/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.
Vascular disorders HYPERTENSION NOS	5.4% 14/259 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.3% 19/262 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	5.1% 13/256 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	7.4% 19/258 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.0% 16/268 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.	6.2% 16/260 • The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred. Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.

Additional Information

Jennifer G Wright

CDC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PIs must have the approval of all 5 PIs to conduct and publish additional research using clinical trial data or specimens
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